Osimertinib compared to docetaxel-bevacizumab as third-line treatment in EGFR T790M mutated non-small cell lung cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9017-9017 ◽  
Author(s):  
Keke Nie ◽  
Zhongfa Zhang ◽  
Xiao Zou ◽  
Chunling Zhang ◽  
Xingjun Zhuang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Response Rate ◽  
Resistance Mutation ◽  
Progression Free Survival ◽  
Line Treatment ◽  
T790m Mutation ◽  
Free Survival ◽  
Third Line ◽  
Egfr T790m ◽  
Third Line Treatment

9017 Background: Osimertinib, an oral irreversible EGFR tyrosine kinase inhibitor, had promising results in patients with EGFR T790M resistance mutation of non-small-cell lung cancer (NSCLC). This study compared efficacy and toxicities of osimertinib versus docetaxel -bevacizumab as third-line treatment in EGFR T790M mutated NSCLC. Methods: In this phase 3, open-label, three-center study, we randomly assigned previously treated with TKI-chemotherapy or chemotherapy-TKI recurrent or metastatic advanced non-squamous lung cancer patients who had acquired EGFR T790M resistance mutation confirmed by tumor tissues or serum genetic test. Patients were randomly assigned in a ratio of 1:1 to receive oral osimertinib (80mg/day) or receive intravenous infusion docetaxel (75mg/m2) and bevacizumab (7.5mg/kg) until disease progression or unacceptable toxic effects. Docetaxel -bevacizumab group patients might crossover to osimertinib group after disease progression. The primary end-point of this study was progression-free survival and the secondary end-point were response rates, toxicities and OS. Results: A total of 147 patients were treated. Among them, 74 enrolled in the osimertinib group and 73 in the docetaxel-bevacizumab group. The median progression-free survival was 10.20 months and 2.95 months in the osimertinib group and docetaxel -bevacizumab group respectively (Hazard ratio 0.23; 95% confidence interval, 0.12 to 0.38; P < 0.0001). The overall response rate and disease control rate was 61.6% or 87.6% in osimertinib group 8.3% or 43.0% in docetaxel-bevacizumab group respectively. The median overall survival time was not reached. The main grade 3 or 4 toxic effects were diarrhea (2.7%) and interstitial lung disease (1.2%) in the osimertinib group and alopecia (15.1%), anorexia (12.3%), neutropenia (9.6%) and nausea (8.6%) in docetaxel -bevacizumab group. Conclusions: Response rate and progression-free survival of osimertinib group were superior to docetaxel-bevacizumab group in third-line treatment of EGFR T790M positive NSCLC. There was no survival difference between patients with EGFR 19 Del-T790M mutation and EGFR L858R-T790M mutation. Clinical trial information: NCT02959749.

Anlotinib combined with s-1 in the third-line or later-line treatment of stage IV non-small cell lung cancer: Study for phase II clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21115-e21115
Author(s):  
Xiyue Yang ◽  
Xiaobo Du
Keyword(s):  
Lung Cancer ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Small Cell ◽  
Line Treatment ◽  
Small Cell Lung ◽  
Free Survival ◽  
The Third ◽  
Third Line ◽  
Third Line Treatment

e21115 Background: At present, for stage IV non-small-cell lung cancer (NSCLC), after the failure of second-line treatment, the effective rate of third-line treatment is not very well. We designed this study to evaluate the efficacy and safety of anlotinib combined with S-1 as a third-line treatment for patients with stage IV NSCLC. Methods: According to the inclusion and exclusion criteria, 29 patients will be treated with anlotinib plus S-1 based on Simon’s optimal two-stage design.They will undergo computed tomography (CT) every two cycles to assess the therapeutic effect according to RECIST.If the efficacy is assessed as SD, PR, CR after six cycles, anlotinib will be maintained until disease progression or death. Statistical analysis of the data will be conducted using SPSS (version 22.0).The primary endpoint is the objective response rate (ORR). The secondary endpoints are disease control rate(DCR),progression-free survival(PFS), overall survival(OS), and safety. Results: Between Jan 10, 2019, and Oct 31, 2020, a total of 29 patients were enrolled for treatment.At data cutoff (Jan 11, 2021),27(93.1%) patients had discontinued the study, and 2 (6.9%) patients were still receiving treatment. The median follow-up time was 11.2 months (IQR 8.2-20.1). Objective responses were achieved in 11 (37.9%; 95%CI 20.7-57.7) of 29 patients in the intention-to-treat population,which reached this trial’s primary endpoint. Disease control was achieved in 18 patients (62.1%; 95%CI 42.3-79.3);The median overall survival was 16.7months (95%CI 14.9-18.6);the median progression-free survival was 5.8 months (95% CI 2.9-8.7). The most common grade 3 adverse events were Gastrointestinal reactions (3[10.3%]),Fatigue (2[6.9%]), and Hypertension (2 [6.9%]).No grade 4 treatment-related adverse events, or treatment-related deaths occurred. Conclusions: The combination of anlotinib with S-1 in the third-line or later-line treatment of stage IV NSCLC shows promising anti-tumour activity and manageable toxicities in patients with NSCLC, and further study in phase 3 trials will be planned in the future. Clinical trial information: ChiCTR1900020948.

Clinical implications of the T790M mutation in disease characteristics and treatment response in patients with EGFR-mutated NSCLC.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9031-9031
Author(s):  
Daria Gaut ◽  
Myung Shin Sim ◽  
Brian R. Wolf ◽  
Phillip A. Abarca ◽  
James M. Carroll ◽  
...  
Keyword(s):  
Medical Records ◽  
Response Rate ◽  
Kinase Inhibitor ◽  
Resistance Mutation ◽  
Progression Free Survival ◽  
First Line ◽  
T790m Mutation ◽  
Free Survival ◽  
Egfr Mutant ◽  
Nsclc Patients

9031 Background: The secondary T790M mutation accounts for more than 50% of acquired tyrosine kinase inhibitor (TKI) resistance in epidermal growth factor receptor (EGFR)-mutant NSCLC patients. Recent reports suggest this resistance mutation may be more common among patients with longer progression-free survival (PFS) on first-line TKI therapy, but much is still unknown about this resistance mechanism’s association with response to other therapies. Methods: Our group collected medical records from patients who underwent a biopsy for T790M mutation testing in the process of screening for clinical trials involving third generation EGFR inhibitors. Medical records were retrospectively analyzed for demographic data, PFS, best response (BR) to previous therapies, and presence or absence of an acquired T790M mutation. Progression-free survival was estimated using the Kaplan-Meier method and compared across two groups using the log-ranked test followed by univariate and multivariate cox proportional hazard regression analysis. Response rates were compared using Fisher’s exact test. Results: Out of 102 patients who obtained a diagnostic biopsy, 73 patients had a T790M mutation. Patients who later developed a T790M mutation had a longer PFS on first-line TKI therapy (12.0 months in T790M+ vs. 8.0 months in T790M-, p = 0.038, HR 1.66, 95% CI 1.03-2.67), though there was no difference in response rate (75.5% in T790M+ vs 77.3% in T790M-, p = 1.00). T790M+ patients also had a longer PFS on initial chemotherapy treatment (5.0 months in T790M+ vs. 4.0 months in T790M-, p = 0.020, HR 1.97, 95% CI 1.11-3.49) and a higher response rate to chemotherapy (22.7% in T790M+ vs 0% in T790M-, p = 0.033). Median PFS was short (3.0 months) for patients treated with immunotherapy with no difference based on T790M mutation status (p = 0.33). Conclusions: Our study confirms that tumors expressing T790M have a more indolent progression of disease compared to their T790M negative counterparts when treated with both first-line TKI and cytotoxic chemotherapy. This data provides context for therapeutic decision making in EGFR-mutant NSCLC patients.

scholarly journals Benchmark of Progression Free Survival for Multiple Lines of Therapy in Follicular Lymphoma Treated in the Rituximab Era

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2955-2955 ◽  
Author(s):  
Anna Alperovich ◽  
Connie Batlevi ◽  
Katy Smith ◽  
Zhitao Ying ◽  
Jacob D Soumerai ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Board Of Directors ◽  
Research Funding ◽  
Progression Free Survival ◽  
Complete Response ◽  
Line Treatment ◽  
Advisory Committees ◽  
Free Survival ◽  
Third Line ◽  
Third Line Treatment

Abstract Introduction In their lifetime, patients with follicular lymphoma frequently require multiple treatments, which have improved their survival over the past few decades. The expected treatment outcome based on lines of treatment in the post-Rituximab era is currently unknown. We analyzed the progression free survival and event free survival by line of treatment to aid estimating clinical endpoints when designing future clinical trials for multiply relapsed patients. Patients and Methods Adults (≥18 years) with de novo follicular lymphoma (FL) treated at our center between 1998 and 2007 were eligible (N=1134). 236 patients with ≤2 visits, mixed histology at initial diagnosis, and active concurrent malignancy were excluded. Of the remaining 898 patients, 105 were observed and did not require treatment during the timeframe of this dataset, and 2 had incomplete data, therefore 791 patients were eligible for response, progression and event free survival (PFS and EFS) analysis (Figure 1). Response was documented by investigators based on clinical or radiographic assessment. Complete response was based on radiographic assessment. PFS was defined as start of treatment to progression of disease or death. Patients with inadequate response to treatment, change of treatment, or stable disease without subsequent documented relapse were censored in the PFS analysis. Events for EFS were defined as progression, change of treatment, and death. PFS and EFS of sequential lines of treatment were evaluated by Kaplan-Meier method and compared across lines using log-rank test with adjustment for within-patient correlation. PFS and EFS were compared by other clinical variables using regular log-rank tests. Results Median age of diagnosis was 57.3 years with 1:1 male to female ratio. Median overall survival was not reached with median follow up of 9 years (N=898, range 0.2 - 16.8 years, Figure 1A). Median time to first treatment for the entire group was 2.3 months (range 0 - 13.3 years). In first line treatment of the 791 patients, 51% (N=406) received Rituximab with chemotherapy (R-Chemo), 13% (N=101) received chemotherapy only (Chemo), 19% (N=150) received Rituximab monotherapy (R-Mono), and 17% (N=129) received other treatments including radiation and surgery. For second line treatment, 405 patients were treated with about 37% receiving R-Chemo and 34% receiving R-Mono. As line of treatment increased, the percentage of patients with radiographically assessed complete response diminished from 71% at first line treatment to 25% by fifth line treatment (Figure 1B). Median PFS for first, second and third line treatment are 4.8, 1.6, and 1 year, respectively (Figure 2A). Median EFS for first, second and third line treatment are 3.8, 1.1, 0.8 year, respectively (Figure 2B). For subsequent lines of treatment, both median PFS and EFS were <1 year. Conclusion Follicular lymphoma is an indolent disease often requiring multiple lines of treatment. However, PFS and EFS for multiple lines of treatment in FL has not been described in the post-Rituximab era. The work has benchmarked the median response by line of treatment. After third line treatment, the PFS was ≤1 year. This analysis serves to aide comparison of different therapies for future drug approval in relapsed FL. Disclosures Hamlin: Xencor: Membership on an entity's Board of Directors or advisory committees; Portola: Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees; Molecular Templates: Research Funding; Novartis: Research Funding; Seattle Genetics: Research Funding; Gilead: Membership on an entity's Board of Directors or advisory committees. Horwitz:Spectrum: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy; Huya: Consultancy; Infinity: Consultancy, Research Funding; Kyowa Hakka Kirin: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Celgene: Consultancy; ADCT Therapeutics: Research Funding. Kumar:Celgene: Honoraria, Other: Scientific Advisory Board; Celgene: Research Funding; Adaptive Biotechnologies: Research Funding; Seattle Genetics: Research Funding; Pharmacyclics: Research Funding. Moskowitz:Merck: Honoraria; Seattle Genetics: Honoraria, Research Funding; Bristol Myers Squibb: Honoraria. Moskowitz:Merck: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding. Palomba:Pharmacyclics: Consultancy. Zelenetz:Gilead Sciences: Research Funding.

Gemcitabine and capecitabine as third-line treatment in patients with metastatic colorectal cancer after failure of irinotecan and oxaliplatin.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 620-620 ◽  
Author(s):  
M. Qiu ◽  
F. Bi ◽  
J. Liu ◽  
Q. Li ◽  
C. Yi
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Performance Status ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Disease Stabilization ◽  
Third Line ◽  
Third Line Treatment

620 Background: There is no standard chemotherapeutic regimen for patients with advanced colorectal cancer (CRC) progressing after combination regimens including irinotecan and oxaliplatin and having good performance status. 5-FU and gemcitabine are synergistic in preclinical studies of colon cancer cells. And gemcitabine also increases intracellular release of 5-FU from capecitabine. The aim of this study is to evaluate the efficacy and tolerance of the gemcitabine/capecitabine combination as third-line treatment for patients with advanced colorectal cancer. Methods: Between May 2007 and September 2009, the data on 12 patients with metastatic colorectal cancer after failure of irinotecan- and oxaliplatin-containing regimens reviewed retrospectively. The median patient age was 54.0 years (range 37-77). The ECOG performance status was 0, 1 or 2. All patients has 2 or more previous chemotherapy. Patients received GemCap regimen (oral capecitabine 1,000 mg/m2 twice daily on days 1 to 14 plus Gem 1,000 mg/m2 on days 1 and 8 every 3 weeks). Eleven patients were evaluable for the response and all patients were evaluable for toxicity. Results: No partial response was achieved and disease stabilization in 4 (36.4.3%) cases. Median progression-free survival and median overall survival were 9.1 weeks (range 3.0-18.0) and 22.3 weeks (range 10.5- 53.0). Four patients with disease stabilization had longer median progression-free survival than those with disease progression (13 weeks vs. 6.2 weeks). No toxic deaths occurred. Grade 3 toxicities were thrombocytopenia (in 2 patients), neutropenia (in 2 patients) and mucositis (in 1 patient), hand-foot syndrome (in 1 patient) and GI toxicity (in 2 patients). Conclusions: The combination of gemcitabine and capecitabine was found to be a safe palliative regimen for heavily pretreated patients with metastatic CRC. Despite no patients had radiologic response, patients with disease stabilization achieved better progression-free survival. This regimen seems to be potentially effective regimen in the treatment of CRC. No significant financial relationships to disclose.

Effectiveness and safety of pembrolizumab monotherapy in patients with locally advanced or metastatic non-small-cell lung cancer

2021 ◽  
pp. 107815522110611
Author(s):  
Rocio Tamayo-Bermejo ◽  
Juan Carlos del Rio-Valencia ◽  
Beatriz Mora-Rodriguez ◽  
Isabel Muñoz-Castillo
Keyword(s):  
Lung Cancer ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Small Cell ◽  
Line Treatment ◽  
Small Cell Lung ◽  
First Line ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Third Line

Introduction Immunotherapy has become a standard treatment for lung cancer; the objective of this study was to evaluate the effectiveness, safety of pembrolizumab monotherapy in patients with advanced or metastatic non-small-cell lung cancer used in real-world clinical practice. Material and methods Retrospective observational study of every patient treated with pembrolizumab in our centre from January 2017 to June 2019. Outcomes collected: sex, age, Eastern Cooperative Oncology Group, programmed death receptor 1 level, previous metastatic line therapies, adverse events and smoking status. Results A total of 62 patients were reviewed. The median age was 62.34 ± 10.62 years, 48 (77.41%) were men and 91.93% of patients had Eastern Cooperative Oncology Group 0. The median dose administered was 170.5 mg (108 – 240 mg) and the median follow-up was 3 months (range: 1 – 38). A median of four cycles of pembrolizumab (range: 1 – 56) were administered as monotherapy. The reason for treatment discontinuation was mainly due to disease progression in 38.70% of patients or death in 30.64%. As first-line pembrolizumab monotherapy, median progression-free survival was 7.7 months (95% CI: 3.66 – 11.73) ( N = 33). With respect to patients who were treated in second–third-line treatment, median progression-free survival was 3.5 months (95% CI: 2.40 – 4.59) ( N=29). As to overall survival, pembrolizumab-treated patients as first-line treatment reached 19 months median OG (95% CI: 13.36 – 24.63) ( N = 33) and those treated in second–third-line treatment got 11 months (95% CI: 3.4 – 18.5). A total of 64.51% of patients presented some adverse events to pembrolizumab however, only, 9.38% of them were grade 3. Conclusion Pembrolizumab represents an effective and feasible alternative in terms of progression-free survival. It is a well-tolerated treatment option.

scholarly journals Erlotinib and bevacizumab versus cisplatin, gemcitabine and bevacizumab in unselected nonsquamous nonsmall cell lung cancer

2015 ◽  
Vol 46 (1) ◽  
pp. 219-229 ◽  
Author(s):  
Michael Thomas ◽  
Jürgen Fischer ◽  
Stefan Andreas ◽  
Cornelius Kortsik ◽  
Christian Grah ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Progression Free Survival ◽  
Nonsmall Cell Lung Cancer ◽  
Line Treatment ◽  
First Line ◽  
Free Survival ◽  
First Line Treatment

Erlotinib with bevacizumab showed promising activity in recurrent nonsquamous (NS) nonsmall cell lung cancer (NSCLC). The INNOVATIONS study was designed to assess in first-line treatment of unselected cisplatin-eligible patients this combination compared to cisplatin, gemcitabine and bevacizumab.Stage IIIB/IV patients with NS-NSCLC were randomised on erlotinib (150 mg daily) and bevacizumab (15 mg·kg−1 on day 1, every 3 weeks) (EB) until progression, or cisplatin (80 mg·m−2 on day 1, every 3 weeks) and gemcitabine (1250 mg·m−2 on days 1 and 8, every 3 weeks) up to six cycles and bevacizumab (15 mg·kg−1 on day 1, every 3 weeks) (PGB) until progression.224 patients were randomised (EB n=111, PGB n=113). The response rate (12% versus 36%; p<0.0001), progression-free survival (median 3.5 versus 6.9 months; hazard ratio (HR) 1.85, 95% CI 1.39–2.45; p<0.0001) and overall survival (median 12.6 versus 17.8 months; HR 1.41, 95% CI 1.01–1.97; p=0.04) clearly favoured PGB. In patients with epidermal growth factor receptor mutations (n=32), response rate, progression-free survival and overall survival were not superior with EB.Platinum-based combination chemotherapy remains the standard of care in first-line treatment of unselected NS-NSCLC. Molecular targeted approaches strongly mandate appropriate testing and patient selection.

Osimertinib compared docetaxel-bevacizumab as third-line treatment in EGFR T790M mutated non-small-cell lung cancer

Lung Cancer ◽  
2018 ◽  
Vol 121 ◽  
pp. 5-11 ◽  
Author(s):  
Keke Nie ◽  
Zhongfa Zhang ◽  
Chunling Zhang ◽  
Chuanxin Geng ◽  
Ling Zhang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Line Treatment ◽  
Small Cell Lung ◽  
Third Line ◽  
Egfr T790m ◽  
Third Line Treatment

scholarly journals Osimertinib in Advanced EGFR-T790M Mutation-positive Non-small Cell Lung Cancer Patients Treated Within the Special Use Medication Program in Spain. OSIREX-spanish Lung Cancer Group

2020 ◽  
Author(s):  
Mariano Provencio ◽  
Josefa Terrasa ◽  
Pilar Garrido ◽  
Rosario García Campelo ◽  
Francisco Aparisi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Egfr T790m

Abstract Background: AURA study reported 61% objective response rate and progression-free survival of 9.6 months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain.Methods: Post-authorization, non-interventional Special Use Medication Program, multicenter, retrospective study in advanced EGFR/T790M+ non-small cell lung cancer. 155 patients were enrolled (August 2016-December 2018) from 30 sites. Primary objective: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources.Results: 70% women, median age 66. 63.9% were non-smokers and 99% had adenocarcinoma. Most had received at least one prior treatment (97%), 91.7% had received previous EGFR-tyrosine kinase inhibitors and 2.8% osimertinib as first-line treatment. At data cutoff, median follow-up was 11.8 months. 155 patients were evaluable for response, 1.3% complete response, 40.7% partial response, 31% stable disease and 11.6% progressive disease. Objective response rate was 42%. Median progression-free survival was 9.4 months. 49% reported an adverse event, the majority of which (78%) were grade 1 or 2. The resource cost study indicates early use is warranted. Conclusion: This study to assess the real-world clinical impact of osimertinib showed high drug activity in pretreated advanced EGFR/T790M+ non-small cell lung cancer, with manageable adverse events.Clinical trial registration number: NCT03790397

scholarly journals Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain: OSIREX-Spanish Lung Cancer Group

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariano Provencio ◽  
Josefa Terrasa ◽  
Pilar Garrido ◽  
Rosario García Campelo ◽  
Francisco Aparisi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Egfr T790m

Abstract Background AURA study reported 61% objective response rate and progression-free survival of 9.6 months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain. Methods Post-authorization, non-interventional Special Use Medication Program, multicenter, retrospective study in advanced EGFR/T790M+ non-small cell lung cancer. One hundred-fifty five patients were enrolled (August 2016–December 2018) from 30 sites. Primary objective: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources. Results 70% women, median age 66. 63.9% were non-smokers and 99% had adenocarcinoma. Most patients had received at least one prior treatment (97%), 91.7% had received previous EGFR-tyrosine kinase inhibitors and 2.8% osimertinib as first-line treatment. At data cutoff, median follow-up was 11.8 months. One hundred-fifty five patients were evaluable for response, 1.3% complete response, 40.6% partial response, 31% stable disease and 11.6% disease progression. Objective response rate was 42%. Median progression-free survival was 9.4 months. Of the 155 patients who received treatment, 76 (49%) did not reported any adverse event, 51% presented some adverse event, most of which were grade 1 or 2. The resource cost study indicates early use is warranted. Conclusion This study to assess the real-world clinical impact of osimertinib showed high drug activity in pretreated advanced EGFR/T790M+ non-small cell lung cancer, with manageable adverse events. Trial registration Clinical trial registration number:NCT03790397.

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