Combination Chemotherapy With Carboplatin, Docetaxel, and Gemcitabine in Advanced Non–Small-Cell Lung Cancer: A Phase II Study

1999 ◽  
Vol 17 (12) ◽  
pp. 3816-3821 ◽  
Author(s):  
D. Pectasides ◽  
A. Aspropotamitis ◽  
A. Halikia ◽  
A. Visvikis ◽  
F. Antoniou ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Objective Response ◽  
Area Under The Curve ◽  
Stage Iv ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3

PURPOSE: To evaluate the efficacy and toxicity of the combination of carboplatin, docetaxel, and gemcitabine in patients with advanced non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Forty-five chemotherapy-naive patients with NSCLC were treated on an out-patient basis with carboplatin area under the curve 5 intravenous (IV) and gemcitabine 800 mg/m2 IV on day 1 and docetaxel 75 mg/m2 IV and gemcitabine 800 mg/m2 IV on day 8. Granulocyte colony-stimulating factor (150 ug/m2 subcutaneously) was given prophylactically from day 3 to day 6 and day 10 to day 16. Chemotherapy was repeated every 4 weeks. Patients were evaluated for response every two cycles of treatment. RESULTS: The median age of the patients was 58 years (range, 24 to 75 years). The performance status was 0 for 16 patients, 1 for 17 patients, and 2 for 12 patients. Nine patients (20%) had stage IIIB disease, and 36 (80%) had stage IV; histology was mainly squamous cell carcinoma (51.2% of patients) that was poorly differentiated (37.8%). All 45 patients were assessable for toxicity, and 41 were assessable for response. On an intent-to-treat analysis, the objective response rate was 46.5% (21 out of 45 patients; 95% confidence interval [CI], 31.7% to 62.5%). Of the 45 patients, four (8.8%) achieved a complete response (95% CI, 2.5% to 21.2%); 17 (37.7%) achieved a partial response (95% CI, 23.8% to 53.5%); seven (15.5%) had stable disease; and 14 (31.1%) had progressive disease. The median survival time was 13.5 months, and the actuarial 1-year survival rate was 51.11%. The median duration of response was 7.6 months, and the time to tumor progression was 8.1 months. Grade 3/4 anemia and thrombocytopenia occurred in 17.7% and 28.8% of patients, respectively. Twenty-one patients (46.6%) developed grade 3/4 neutropenia, and six patients (13.3%) were complicated with fever. Alopecia was universal. Grade 3 diarrhea occurred in four patients (8.8%); grade 3/4 neurotoxicity occurred in 10 patients (22.2%); and grade 2/3 allergic reaction occurred in three patients (16.6%). There were no treatment-related deaths. Six patients (13.3%) required a dose reduction, two of which required two reductions. CONCLUSIONS: The combination of carboplatin, docetaxel, and gemcitabine is an effective regimen for the treatment of chemotherapy-naive patients with advanced NSCLC, causing only moderate toxicity.

Amifostine, cisplatin, and vinblastine in metastatic non-small-cell lung cancer: a report of high response rates and prolonged survival.

1996 ◽  
Vol 14 (6) ◽  
pp. 1913-1921 ◽  
Author(s):  
J H Schiller ◽  
B Storer ◽  
J Berlin ◽  
J Wittenkeller ◽  
M Larson ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Objective Response ◽  
Small Cell ◽  
Small Cell Lung ◽  
Computed Tomographic ◽  
Metastatic Nsclc ◽  
Grade 3

PURPOSE Based on preclinical and clinical studies that suggested amifostine may potentiate the effects of cytotoxic drugs, we conducted a phase II trial of amifostine, cisplatin, and vinblastine (ACV) in patients with metastatic non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS Twenty-five patients with metastatic NSCLC received amifostine (740 or 910 mg/m2) before 120 mg/m2 of cisplatin on day 1, plus weekly 5 mg/m2 of vinblastine without amifostine. Cycles were repeated every 4 weeks. Patients were required to have good performance status, no prior chemotherapy or biologic therapy, adequate organ function, and measurable disease. RESULTS Sixteen of 25 assessable patients had an objective response documented by computed tomographic (CT) scan (64%; 95% confidence interval, 45% to 85%). With a median duration of follow-up of 19.2 months, the estimated median survival is 17 months and 1-year survival is 64% (+/- 10%). Toxicities included grades 3 and 4 neutropenia (8% and 92%, respectively) and nausea and vomiting (32% and 4%, respectively). Reversible grade 3 nephrotoxicity occurred in 12% of patients, although only one of 13 patients (7%) who received > or = four cycles of therapy had > or = 40% reduction in creatinine clearance. Grade 3 neuropathy was observed in seven patients at cumulative cisplatin doses that ranged from 324 to 660 mg/m2; grade 3 ototoxicity occurred in three patients at cumulative cisplatin doses that ranged from 390 to 450 mg/m2. Four patients (16%) required early stopping of an amifostine infusion due to hypotension. CONCLUSION ACV appears to be a highly active regimen in metastatic NSCLC. Acute toxicities were generally reversible and the data suggest that amifostine may protect against long-term renal insufficiency from cumulative doses of cisplatin. Although the sample size of this trial is small, the results are significantly encouraging to warrant confirmation in randomized multiinstitutional trials.

Front-Line Treatment of Advanced Non–Small-Cell Lung Cancer With Docetaxel and Gemcitabine: A Multicenter Phase II Trial

1999 ◽  
Vol 17 (3) ◽  
pp. 914-914 ◽  
Author(s):  
Vassilis Georgoulias ◽  
Charalambos Kouroussis ◽  
Nikos Androulakis ◽  
Stelios Kakolyris ◽  
Meletios-Athanasios Dimopoulos ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Stage Iv ◽  
Small Cell ◽  
World Health ◽  
Small Cell Lung ◽  
Grade 3 ◽  
Health Organization

PURPOSE: To evaluate the tolerance and efficacy of the combination of docetaxel and gemcitabine in patients with advanced non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Fifty-one chemotherapy-naive patients with NSCLC were treated with gemcitabine 900 mg/m2 intravenously on days 1 and 8 and docetaxel 100 mg/m2 intravenously on day 8 with granulocyte colony-stimulating factor (150 μg/m2, subcutaneously) support from day 9 to day 15. Treatment was repeated every 3 weeks. RESULTS: The patients' median age was 64 years. The World Health Organization performance status was 0 to 1 in 39 patients and 2 in 12 patients. Fifteen patients (29%) had stage IIIB disease, and 36 (71%) had stage IV; histology was mainly squamous cell carcinoma (59%). A partial response was achieved in 19 patients (37.5%; 95% confidence interval, 24% to 50%); stable disease and progressive disease were each observed in 16 patients (31.4%). The median duration of response and the time to tumor progression were 5 and 6 months, respectively. The median survival was 13 months, and the actuarial 1-year survival was 50.7%. Grade 4 anemia and thrombocytopenia were rare (2%). Four patients (8%) developed grade 3 or 4 neutropenia, and all were complicated with fever; there was no treatment-related death. Grade 3 or 4 diarrhea occurred in three patients (6%), grade 2 or 3 neurotoxicity in four patients (8%), grade 2 or 3 asthenia in 10 patients (20%), and grade 2 or 3 edema in 10 patients (20%). CONCLUSION: The combination of docetaxel/gemcitabine is well tolerated, can be used for outpatients, and is active for the treatment of advanced NSCLC. This treatment merits further comparison with other cisplatin- or carboplatin-based combinations.

Multicenter Phase I/II Study of Cetuximab With Paclitaxel and Carboplatin in Untreated Patients With Stage IV Non–Small-Cell Lung Cancer

2005 ◽  
Vol 23 (34) ◽  
pp. 8786-8793 ◽  
Author(s):  
Christiane D. Thienelt ◽  
Paul A. Bunn ◽  
Nasser Hanna ◽  
Arthur Rosenberg ◽  
Michael N. Needle ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Median Survival ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Objective Response ◽  
Stage Iv ◽  
Small Cell ◽  
Time To Progression ◽  
Small Cell Lung

Purpose Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors have demonstrated antitumor activity in patients with non–small-cell lung cancer (NSCLC). This study examined the safety profile of the monoclonal antibody EGFR inhibitor, cetuximab, when added to paclitaxel and carboplatin in untreated patients with stage IV NSCLC. Secondary objectives included efficacy and paclitaxel and carboplatin pharmacokinetics during cetuximab treatment. Patients and Methods Patients with tumor evidence of EGFR by immunohistochemistry, performance status of 0 to 2, and measurable disease received paclitaxel 225 mg/m2 with carboplatin area under the curve = 6 on day 1 every 3 weeks. Cetuximab was administered at 400 mg/m2, 1 week before paclitaxel and carboplatin, then weekly at 250 mg/m2. The regimen continued until disease progression or intolerable toxicity. Results Thirty-one of 32 enrolled patients were treated. The most common cetuximab toxicity was rash in 84% of patients (grade 3 in 13%). Pharmacokinetic sampling did not reveal an interaction between carboplatin, paclitaxel, and cetuximab. An objective response was observed in eight patients (26%). With a median follow-up of 19 months, the median time to progression was 5 months, median survival was 11 months, and the 1- and 2-year survival rates were 40% and 16%, respectively. Conclusion The combination of cetuximab, paclitaxel, and carboplatin was safe and well tolerated in this population of stage IV patients. The response rate, time to progression, and median survival were slightly superior to historical controls treated with paclitaxel and carboplatin alone. A randomized phase II trial has completed accrual.

Irinotecan Plus Carboplatin Versus Oral Etoposide Plus Carboplatin in Extensive Small-Cell Lung Cancer: A Randomized Phase III Trial

2008 ◽  
Vol 26 (26) ◽  
pp. 4261-4267 ◽  
Author(s):  
Andreas Hermes ◽  
Bengt Bergman ◽  
Roy Bremnes ◽  
Lars Ek ◽  
Sverre Fluge ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Area Under The Curve ◽  
Small Cell ◽  
Phase Iii ◽  
Oral Etoposide ◽  
Small Cell Lung ◽  
Grade 3

Purpose A Japanese randomized trial showed superior survival for patients with extensive-disease (ED) small-cell lung cancer (SCLC) receiving irinotecan plus cisplatin compared with etoposide plus cisplatin. The present trial evaluated the efficacy of irinotecan plus carboplatin (IC) compared with oral etoposide plus carboplatin (EC). Patients and Methods Patients with ED SCLC were randomly assigned to receive either IC, which consisted of carboplatin (area under the curve = 4; Chatelut formula) and irinotecan (175 mg/m2) intravenously both on day 1, or EC, which consisted of carboplatin as in IC and etoposide (120 mg/m2/d) orally on days 1 through 5. Courses were repeated every 3 weeks with four cycles planned. Doses were reduced by one third in patients with a WHO performance status (PS) of 3 to 4 and/or age older than 70 years. Primary end point was overall survival (OS). Secondary end points were quality of life (QOL) and complete response (CR) rate. Results Of 220 randomly assigned patients, 209 were eligible for analysis (IC, n = 105; EC, n = 104). Thirty-five percent were older than 70 years, and 47% had a PS of 2 to 4. The groups were well balanced with respect to prognostic factors. OS was inferior in the EC group (hazard ratio = 1.41; 95% CI, 1.06 to 1.87; P = .02). Median survival time was 8.5 months for IC compared with 7.1 months for EC. One-year survival rate was 34% for IC and 24% for EC. CR was seen in 18 IC patients compared with seven EC patients (P = .02). There were no statistically significant differences in hematologic grade 3 or 4 toxicity. Grade 3 or 4 diarrhea was more common in the IC group. QOL differences were small, with a trend toward prolonged palliation with the IC regimen. Conclusion IC prolongs survival in ED SCLC with slightly better scores for QOL.

Phase II Study of Pemetrexed and Carboplatin Plus Bevacizumab With Maintenance Pemetrexed and Bevacizumab As First-Line Therapy for Nonsquamous Non–Small-Cell Lung Cancer

2009 ◽  
Vol 27 (20) ◽  
pp. 3284-3289 ◽  
Author(s):  
Jyoti D. Patel ◽  
Thomas A. Hensing ◽  
Alfred Rademaker ◽  
Eric M. Hart ◽  
Matthew G. Blum ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Objective Response ◽  
Small Cell ◽  
Phase Iii ◽  
Hematologic Toxicity ◽  
Small Cell Lung ◽  
Time Curve ◽  
Grade 3

PurposeThis study evaluated the efficacy and safety of pemetrexed, carboplatin, and bevacizumab followed by maintenance pemetrexed and bevacizumab in patients with chemotherapy-naive stage IIIB (effusion) or stage IV nonsquamous non–small-cell lung cancer (NSCLC).Patients and MethodsPatients received pemetrexed 500 mg/m2, carboplatin area under the concentration-time curve of 6, and bevacizumab 15 mg/kg every 3 weeks for six cycles. For patients with response or stable disease, pemetrexed and bevacizumab were continued until disease progression or unacceptable toxicity.ResultsFifty patients were enrolled and received treatment. The median follow-up was 13.0 months, and the median number of treatment cycles was seven (range, one to 51). Thirty patients (60%) completed ≥ six treatment cycles, and nine (18%) completed ≥ 18 treatment cycles. Among the 49 patients assessable for response, the objective response rate was 55% (95% CI, 41% to 69%). Median progression-free and overall survival rates were 7.8 months (95% CI, 5.2 to 11.5 months) and 14.1 months (95% CI, 10.8 to 19.6 months), respectively. Grade 3/4 hematologic toxicity was modest—anemia (6%; 0), neutropenia (4%; 0), and thrombocytopenia (0; 8%). Grade 3/4 nonhematologic toxicities were proteinuria (2%; 0), venous thrombosis (4%; 2%), arterial thrombosis (2%; 0), fatigue (8%; 0), infection (8%; 2%), nephrotoxicity (2%; 0), and diverticulitis (6%; 2%). There were no grade 3 or greater hemorrhagic events or hypertension cases.ConclusionThis regimen, involving a maintenance component, was associated with acceptable toxicity and relatively long survival in patients with advanced nonsquamous NSCLC. These results justify a phase III comparison against the standard-of-care in this patient population.

Phase II Study of Weekly Nanoparticle Albumin-Bound Paclitaxel as Second- or Third-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer

Chemotherapy ◽  
2020 ◽  
Vol 65 (1-2) ◽  
pp. 21-28
Author(s):  
Mie Kotake ◽  
Tomohito Kuwako ◽  
Hisao Imai ◽  
Yoshio Tomizawa ◽  
Kyoichi Kaira ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Phase Ii Study ◽  
Performance Status ◽  
Objective Response ◽  
Small Cell ◽  
Small Cell Lung

Introduction: Treatment outcomes in patients with advanced non-small cell lung cancer (NSCLC) are poor due to limited treatment options. Objective: We conducted a multicenter, single-arm phase II study to prospectively assess the efficacy and safety of weekly nab-PTX in patients with advanced NSCLC with failed cytotoxic chemotherapy. Methods: Patients with advanced NSCLC having adequate organ functions with a performance status of 0–1 were enrolled. A 100 mg/m2 dose of nab-paclitaxel was administered on days 1, 8, and 15 of a 28-day cycle. Primary endpoint was the objective response rate (ORR). Secondary endpoints were disease control rate (DCR), toxicity profile, progression-free survival (PFS), and overall survival (OS). Results: Between September 2013 and May 2016, 35 patients were enrolled. The ORR was 31.4%, and the DCR was 74.3%. The median PFS was 3.6 months, and the median OS was 11.4 months. The most common grade 3 or 4 toxicities included neutropenia (54.3%), leukopenia (42.9%), and anemia (11.4%). Two patients discontinued chemotherapy due to pneumonitis. Conclusions: Nab-PTX may be a later-line chemotherapeutic option for previously treated advanced NSCLC.

scholarly journals Bilateral Choroidal Metastasis from Non-Small Cell Lung Cancer

2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Tariq Namad ◽  
Jiang Wang ◽  
Annemarie Tilton ◽  
Nagla Abdel Karim
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Brain Mri ◽  
Stage Iv ◽  
Small Cell ◽  
Small Cell Lung ◽  
Choroidal Metastasis

Breast and lung cancers are the most common primary neoplasms to manifest with choroidal metastases. The incidence of choroidal metastases from metastatic lung cancer was reported to be 2–6.7%. We report a case of bilateral choroidal metastasis from non-small cell lung cancer. A 59-year-old Caucasian female patient, never a smoker, was diagnosed with stage IV lung adenocarcinoma metastatic to the pleura, bones, and the brain. Her initial scan of the chest showed innumerable soft tissue nodules and mediastinal adenopathy compatible with metastatic disease. Her initial brain MRI showed numerous small enhancing lesions consistent with extensive disease. Unfortunately, during her follow-up visits, she presented with bulge on her left eye. Simultaneously, her follow-up chest scan showed increase in the size of the lung nodules. She continued to have a reasonable performance status at that time, except for mild increase in her dyspnea. The choroidal metastases require a multidisciplinary care and should be among the differential patients with malignancy who present with ocular symptoms.

A Phase II Study of S-1 for Previously Untreated Elderly Patients with Advanced Non-Small Cell Lung Cancer

Chemotherapy ◽  
2015 ◽  
Vol 61 (2) ◽  
pp. 93-98 ◽  
Author(s):  
Takashi Kasai ◽  
Yoichi Nakamura ◽  
Minoru Fukuda ◽  
Takeshi Kitazaki ◽  
Seiji Nagashima ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Elderly Patients ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Small Cell ◽  
Small Cell Lung ◽  
Eligibility Criteria ◽  
Grade 3

Background: S-1, a novel oral fluoropyrimidine, is active in the treatment of non-small cell lung cancer (NSCLC). However, data on S-1 for elderly patients with NSCLC are insufficient. Methods: Eligibility criteria were no prior chemotherapy, stage IIIB or IV NSCLC, performance status 0-1, age >70 years, and adequate hematological, hepatic, and renal functions. Patients received S-1 (40 mg/m2 twice a day) for 28 consecutive days. This schedule was repeated every 6 weeks. The primary end point was the tumor response rate. Results: Thirty-two patients were enrolled and 31 patients were evaluable for response. The patients' median age was 80 years (range: 71-88). The response rate was 22.6% (95% CI: 11-38). Neutropenia, anemia, thrombocytopenia, febrile neutropenia, and diarrhea of grade ≥3 occurred in 6, 6, 10, 3, and 3%, respectively. Conclusions: In elderly patients with previously untreated advanced NSCLC, S-1 appears to be well tolerated and demonstrates encouraging activity.

Study KBP-2010-CPHG: Characteristics and management of 968 new cases of small-cell lung cancer (SCLC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19078-e19078
Author(s):  
Charles Dayen ◽  
Daniel Coëtmeur ◽  
Celine Lecerf ◽  
Adrien Diximier ◽  
Bertrand Lemaire ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Primary Lung Cancer ◽  
Stage Iv ◽  
Small Cell ◽  
Small Cell Lung ◽  
Curative Surgery ◽  
Platinum Based Chemotherapy

e19078 Background: In recent years, many major advances have been made in non-small-cell lung cancer (NSCLC), and in particular in adenocarcinoma, but not in SCLC. In 2010, the French College of General Hospital Respiratory Physicians (CPHG) performed a prospective multicentre epidemiological study (KBP-2010-CPHG) to describe the baseline characteristics and management of all new cases of primary lung cancer and to evaluate survival. The present abstract reports results in SCLC patients. Methods: 7,051 patients ≥18 years presenting with a new case of primary lung cancer, histologically or cytologically diagnosed between 1 January and 31 December 2010 and managed in the respiratory department of one of the 104 general hospitals participating in the study, were included. A standardised form was completed for each patient. A steering committee checked data collection exhaustiveness. SCLC data were analysed separately. Results: There were 968 SCLC patients: mean age, 65.6 years (+/-10.6); 23.2% female; 4.4% non-smokers (11 % in women), 35.8% ex-smokers, 59.8% current smokers; 63.4% with performance status 0 or 1; 59.9% having lost weight within the previous 3 months (19.8% of whom had lost >10 kg). Main tumour characteristics at diagnosis were: 71.2% stage IV, 24.7% stage IIIA or IIIB, 4.1% of stage <III. 15.2% of patients received chemo-radiotherapy and 73.4% chemotherapy (86.2% platinum-based). Carboplatin was more commonly used in patients >70 (59.1%) than <70 years of age (40.9 %). One-year mortality was 64.2%. Compared with NSCLC patients, patients with SCLC more frequently were active smokers (59.8% vs.47.6%), lost weight (59.9% vs. 52.4%), and presented with stage IV tumour at diagnosis (71.2% vs. 58.3%); first line therapy was more frequently platinum-based chemotherapy (86.2% vs. 61.2%) and less frequently curative surgery (1.6% vs. 19%), and mortality was higher (64.2% vs. 55.2%). Conclusions: In 2010, prognosis remains poor in SCLC. Compared with NSCLC, it was more frequently associated with active smoking and stage IV disease, and showed a lower rate of surgery.

A phase Ib/II trial of lenvatinib plus pembrolizumab in non-small cell lung cancer.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 16-16 ◽  
Author(s):  
Marcia S. Brose ◽  
Nicholas J. Vogelzang ◽  
Christopher DiSimone ◽  
Sharad K. Jain ◽  
Donald A. Richards ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Objective Response ◽  
Small Cell ◽  
Clinical Activity ◽  
Phase 2 ◽  
Small Cell Lung ◽  
Previously Treated ◽  
Grade 3

16 Background: Lenvatinib (LEN) is a multikinase inhibitor of VEGFR 1−3, FGFR 1−4, PDGFRα, RET, and KIT. Pembrolizumab (PEM), an anti-PD-1 antibody, is an approved monotherapy for previously treated patients (pts) with PD-L1 (+) (tumor proportion score ≥1%) metastatic non-small cell lung cancer (mNSCLC; objective response rate [ORR] 18%). We report interim results of an ongoing phase 1b/2 trial of LEN + PEM in pts with solid tumors, focusing on the mNSCLC cohort. Methods: In this multicenter, open-label study (NCT02501096), pts with measurable, confirmed mNSCLC, ECOG PS ≤1, ≤ 2 prior systemic therapies (phase 2 only) received oral LEN (20 mg/day) and PEM (200 mg Q3W, IV). Pts were not preselected by PD-L1 status. The phase 2 primary end point was ORR at 24 weeks (ORRWK24) by investigator-assessed immune-related RECIST (irRECIST). Secondary end points included ORR, progression-free survival (PFS) and duration of response (DOR). Results: At data cutoff (March 1, 2018), 21 pts were enrolled: 9 (43%) PD-L1(+), 5 (24%) PD-L1(-), and 7 (33%) not tested. Pts were treatment-naïve (14%); or had 1 (33%), 2 (48%), or ≥3 (5%) prior lines of systemic therapy. ORRWK24 was 33.3% (95% CI, 14.6–57.0); other efficacy outcomes are summarized in the table. Grade 3 and 4 treatment-related adverse events (TRAEs) occurred in 48% and 5% (increased aspartate aminotransferase) of pts. There was 1 fatal TRAE (exsanguination; “possibly related” to study treatment). The most common grade 3 TRAEs were hypertension (24%), fatigue (14%), diarrhea (14%), proteinuria (10%), and arthralgia (10%). Conclusions: LEN + PEM showed promising clinical activity and a manageable safety profile in previously treated pts with mNSCLC who were not preselected for PD-L1 status. Further study is warranted.[Table: see text]

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