scholarly journals ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection

2018 ◽  
Vol 19 (4) ◽  
pp. e533-e536 ◽  
Author(s):  
Yi-Long Wu ◽  
Roy S. Herbst ◽  
Helen Mann ◽  
Yuri Rukazenkov ◽  
Marcelo Marotti ◽  
...  
Keyword(s):  
Surgical Resection ◽  
Egfr Mutation ◽  
Early Stage ◽  
Randomized Study ◽  
Phase Iii ◽  
Double Blind ◽  
Early Stage Nsclc ◽  
Complete Surgical Resection

Checkmate 77T: A phase III trial of neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) followed by adjuvant nivo in resectable early-stage NSCLC.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS9076-TPS9076
Author(s):  
Tina Cascone ◽  
Mariano Provencio ◽  
Boris Sepesi ◽  
Shun Lu ◽  
Nivedita Aanur ◽  
...  
Keyword(s):  
Oral Presentation ◽  
Lung Tumor ◽  
Early Stage ◽  
Performance Status ◽  
Unmet Need ◽  
Phase Iii ◽  
Rational Approach ◽  
Controlled Study ◽  
Double Blind ◽  
Early Stage Nsclc

TPS9076 Background: Although surgery for early NSCLC is potentially curative, 5-year overall survival (OS) rates for patients with stage IIA–IIIB disease are historically < 50%, representing a population of high unmet need. Conventional neoadjuvant or adjuvant chemo provides only a 5% absolute improvement in OS at 5 years. A rational approach to improve survival in these patients is to eradicate micrometastatic disease and potentially induce anti-tumor immunity to minimize the risk of relapse with peri-operative regimens including NIVO, a fully human anti–programmed death receptor-1 antibody. Early phase trials indicate that NIVO-based regimens have the potential to deepen pathological responses and extend survival in this setting (Reuss JE et al. Poster presentation at ASCO 2019. Abstract 8524; Cascone T et al. Oral presentation at ASCO 2019. Abstract 8504; Provencio M et al. Oral presentation at WCLC 2019. Abstract OA13.05). Data from the phase 2 single-arm NADIM trial (NCT03081689) demonstrated the highly encouraging major pathological response (MPR) rate of 83% with neoadjuvant NIVO plus chemo followed by adjuvant NIVO in patients with resectable stage IIIA NSCLC (Provencio M et al. Oral presentation at WCLC 2019. Abstract OA13.05). These results require validation in a large randomized controlled study. CheckMate 77T (NCT04025879) is a phase 3, randomized, double-blind trial evaluating neoadjuvant NIVO plus chemo followed by adjuvant NIVO in resectable early stage NSCLC. Methods: Approximately 452 patients aged ≥ 18 years with resectable stage IIA–IIIB (T3N2 only) NSCLC, ECOG performance status 0–1, and available lung tumor tissue will be enrolled at 113 sites in North America, South America, Europe, Asia, and Australia. Patients with EGFR/ALK mutations, brain metastasis, prior systemic anti-cancer treatment or radiotherapy, and autoimmune disease are excluded. Patients will be randomized to receive neoadjuvant NIVO plus carboplatin- or cisplatin-based doublet chemo followed by surgery and adjuvant NIVO, or neoadjuvant placebo plus carboplatin- or cisplatin-based doublet chemo followed by surgery and adjuvant placebo. The primary endpoint is event-free survival, assessed by blinded independent central review. Secondary endpoints include OS, pathological complete response and MPR assessed by blind independent pathological review, safety and tolerability. The start date was September 2019. The estimated primary completion date is May 2023. Clinical trial information: NCT04025879.

scholarly journals The Role of EGFR-TKIs as Adjuvant Therapy in EGFR Mutation-Positive Early-Stage NSCLC: a meta-analysis

2020 ◽  
Author(s):  
Chutong Lin ◽  
Fengling Hu ◽  
Hongling Chu ◽  
Peng Ren ◽  
Shanwu Ma ◽  
...  
Keyword(s):  
Adjuvant Therapy ◽  
Egfr Mutation ◽  
Early Stage ◽  
Meta Analysis ◽  
Early Stage Nsclc ◽  
Egfr Tkis

scholarly journals National Cancer Institute of Canada – Clinical Trials Group (NCIC CTG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 373-401
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Postmenopausal Women ◽  
Primary Breast Cancer ◽  
Randomized Study ◽  
Phase Iii ◽  
Adjuvant Tamoxifen ◽  
Double Blind ◽  
Node Negative ◽  
Increased Risk

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by National Cancer Institute of Canada – Clinical Trials Group (NCIC CTG). Clinical trials include: Double-blind randomized trial of tamoxifen versus placebo in patients with node-positive or high-risk node-negative (tumor ≥ 1 cm and either higher histological grade (poorly differentiated, or SBR grade III or MSBR grade V) or lymphatic/vascular invasion or both) breast cancer who have completed CMF, CEF or AC adjuvant chemotherapy. NCIC CTG Trial MA.12A randomized trial of antiestrogen therapy versus combined antiestrogen and octreotide LAR therapy in the adjuvant treatment of breast cancer in postmenopausal women. NCIC CTG Trial MA.14A phase III randomized double blind study of letrozole versus placebo in women with primary breast cancer completing five or more years of adjuvant tamoxifen. BIG 01-97/NCIC CTG MA.17NCIC CTG MA.17 Companion study (2): The influence of letrozole on bone mineral density in women with primary breast cancer completing five or more years of adjuvant tamoxifen. BIG 01-97/NCIC MA.17BNCIC CTG MA.17 Companion study (1): The influence of letrozole on serum lipid concentrations in women with primary breast cancer who have completed 5 years of adjuvant tamoxifen. BIG 01-97/NCIC CTG MA.17LNCIC CTG MA.17R A double blind re-randomization to letrozole or placebo for women completing 5 years of adjuvant letrozole in the MA.17 study.A phase III study of regional radiation therapy in early breast cancer. NCIC CTG trial MA.20A phase III adjuvant trial of sequenced EC + GCSF Taxol versus sequenced AC → Taxol versus CEF as therapy for premenopausal women and early postmenopausal women who have had potentially curative surgery for node positive or high-risk node negative breast cancer. NCIC CTG Trial MA.21A phase I/II study of increasing doses of epirubicin and docetaxel + pegfilgrastim for locally advanced or inflammatory breast cancer. NCIC CTG Trial MA.22A randomized phase III trial of exemestane versus anastrozole with or without celecoxib in postmenopausal women with receptor positive primary breast cancer. NCIC CTG Trial MA.27A randomized feasibility study of letrozole in postmenopausal women at increased risk for development of breast cancer as evidenced by high breast density. NCIC CTG Trial MAP.1A randomized study of the effect of exemestane (Aromasin) versus placebo on breast density in postmenopausal women at increased risk for development of breast cancer. NCIC CTG Trial: MAP.2A phase III randomized study of exemestane versus placebo in postmenopausal women at increased risk of developing breast cancer. NCIC CTG Trial: MAP.3

Phase III double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea during pelvic radiation therapy: Results of North Central Cancer Treatment Group protocol N00CA

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8506-8506 ◽  
Author(s):  
J. A. Martenson ◽  
J. A. Sloan ◽  
R. L. Deming ◽  
D. B. Wender ◽  
K. J. Stien ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Randomized Study ◽  
Wilcoxon Test ◽  
Phase Iii ◽  
Double Blind Study ◽  
Double Blind ◽  
North Central ◽  
Pelvic Radiation

8506 Background: A randomized study (Int J Rad Oncol Biol Phys 54:195–202, 2002) demonstrated a beneficial effect for octreotide in the treatment of diarrhea in patients receiving pelvic radiation therapy. This North Central Cancer Treatment Group study was undertaken to determine the effectiveness of depot octreotide in the prevention of diarrhea during pelvic radiation therapy. Methods: Patients receiving pelvic radiation therapy, with a planned minimum dose of 45 Gy at 1.70–2.1 Gy per day, were eligible for this study. The study was designed for a Wilcoxon test, with 112 evaluable patients, to have 85% power to detect a further one grade decrease in diarrhea over and above that experienced by patients treated with placebo. Between June 13, 2002 and October 28, 2005, 120 evaluable patients were randomly allocated, in double blind fashion, to receive octreotide (62 patients) or placebo (58 patients), prior to the fourth radiation therapy fraction. Octreotide dosing: Octreotide, 100 micrograms subcutaneously on day 1 followed by depot octreotide, 20 milligrams intramuscularly on days 2 and 29. Results: Grade 0, 1, 2 and 3 diarrhea was observed in 17%, 32%, 26% and 26% of patients treated with octreotide and 18%, 34%, 22%, and 26% of patients treated with placebo (P=0.86). Grade 0, 1, 2 and 3 tenesmus was observed in 55%, 30%, 11% and 4% of patients treated with octreotide and 76%, 16%, 4%, and 4% of patients treated with placebo (P=0.04). No other statistically significant differences in toxicity were observed. Conclusions: Octreotide, as administered in this study, did not decrease diarrhea during pelvic radiation therapy. [Table: see text]

Extent of nodal dissection and patient age impact recurrence-free survival (RFS) after surgery for non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7613-7613
Author(s):  
G. K. Dy ◽  
P. K. Dy ◽  
P. C. Chua ◽  
G. D. Nelson ◽  
N. R. Foster ◽  
...  
Keyword(s):  
Local Recurrence ◽  
Surgical Resection ◽  
Early Stage ◽  
Smoking Status ◽  
Cox Proportional Hazards Model ◽  
Stage Number ◽  
T Stage ◽  
Early Stage Nsclc ◽  
Post Surgery ◽  
Increased Risk

7613 Background: Factors influencing the pattern of disease relapse after curative surgical resection in early stage NSCLC is unknown. We sought to evaluate the effect of tumor- and patient-related characteristics on the pattern of disease recurrence (local relapse and/or metastatic disease) and survival in relation to surgical resection for NSCLC. Methods: A consecutive retrospective series of 488 patients seen at Mayo Clinic Rochester who had complete resection of NSCLC between 1997 and 1998 was utilized. Cox proportional hazards model was used to evaluate the effect of age, gender, smoking status, TNM stage, number of lymph node (LN) involved, number of LN resected, and histopathologic diagnosis on RFS. Logistic regression was used to evaluate the effect on recurrence or death within the first 2 years after surgical resection. Results: Data on 342 patients with a median follow-up of 85 months (range: 0.1 to 162) are reported. 60% were male, and 81% had N0 stage at diagnosis. There were 26 (7.6%) never smokers. Median number of LN resected was 20 (interquartile range [IQR]: 14–29). Median age at surgery was 71 years (IQR: 64 to 76). A bi-modal pattern of local recurrence (N=62) after surgery for early stage NSCLC was observed, with 57% of patients having a local recurrence within 2 years and 21% of patients having a local recurrence from 5–7 years post-surgery. The median duration from surgery to first documented recurrence was 16 months (IQR: 8 to 39). While age, N stage, number of LN involved, and T stage were significant predictors of RFS univariately, only lesser LN resected (p=0.008), older age (p<0.0001) and higher T-stage (p=0.003) were significant adverse predictors of RFS in the multivariate analysis when adjusted for all factors. Higher T-Stage was associated with a significantly increased risk of recurrence or death within the first 2 years after surgical resection (p =0.004). Updated results using data from all 488 patients will be presented in the meeting. Conclusions: A trend towards a bimodal distribution of local recurrences after surgical resection of early stage NSCLC was observed. Increased number of LN resected, younger age and lower T stage were associated with better RFS. No significant financial relationships to disclose.

Update of a phase III trial of adjuvant vinorelbine plus cisplatin (NP) versus NP plus endostar (NPE) in patients with completely resected stage IB-IIIA non-small cell lung cancer (NSCLC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18013-e18013
Author(s):  
He Jie ◽  
Baohui Han ◽  
Yongyu Liu ◽  
Shi Xiu Wu ◽  
Yukang Kuang ◽  
...  
Keyword(s):  
Survival Time ◽  
Early Stage ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Stage Ib ◽  
Early Stage Nsclc ◽  
The Difference ◽  
Grade 3 ◽  
Resected Stage ◽  
Relapsed Disease

e18013 Background: Adjuvant chemotherapy demonstrated a 5-15% benefit in 5-year survival in early-stage NSCLC. Endostar,a recombinant human Endostatin, could inhibit tumor angiogenesis. In a phase III trial, the addition of Endostar to NP regimen resulted in higher response rate, clinical benefit rate and longer median time to progression compared with NP alone in advanced NSCLC patients. Methods: Completely resected patients (stage IB-IIIA) were randomized to receive adjuvant NP plus Endostar (arm A, Vinorelbine 25mg/m2 on d1 and d8 plus Cisplatin 80 mg/m2 intravenously plus Endostar 7.5mg/m2 per day, iv, for 14 consecutive days. 21 days as one cycle(arm A) or NP regimen alone (arm B) for four cycles. The randomization was stratified by gender, stage and histology. The primary endpoint was OS and the secondary endpoints were RFS and safety. Results: 1037 patients (arm A: 520; arm B: 517) from 43 centers in China were enrolled between 9/2007 and 12/2010. Two arms were well-balanced with regard to age, gender, histology, stage, and resection type. 184 patients in arm A and 202 patients in arm B had relapsed disease or died. The median RFS was 34.1 months in arm A and 30.3 months in arm B (p=0.1573). 79.0% of patients in arm A and 76.0% of patients in arm B received 4 cycles of chemotherapy. Median survival time was not available at this time. Grade 3/4 toxicities in arm A included leukopenia (57.4%), neutropenia (75.0%), anemia (12.9%), nausea (11.3%). Grade 3/4 toxicities in arm B included leukopenia (35.0%) neutropenia (60.5%), anemia (8.5%) and nausea (8.5%). It is worth noting that the incidence of cardiac toxicities in arm A (26.3%) was slightly higher than that in arm B (21.4%). Conclusions: The preliminary result showed that patients in arm A experienced a longer median relapse-free survival time than in arm B (34.1 months vs. 30.3 months), although the difference was not statistically significant by far. The toxicity profiles for both arms were tolerable in this study. The patient follow-up is still ongoing.

Association of miR-141 and miR-200c with time to recurrence (TTR) and overall survival (OS) in resected non-small-cell lung cancer (NSCLC) adenocarcinoma (ADC) patients (p).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7547-7547
Author(s):  
Marc Campayo ◽  
Alfons Navarro ◽  
Rut Tejero ◽  
Maria L Cabanas ◽  
Laureano Molins ◽  
...  
Keyword(s):  
Surgical Resection ◽  
Prognostic Value ◽  
Epithelial Mesenchymal Transition ◽  
Early Stage ◽  
Stage I ◽  
Mesenchymal Transition ◽  
Early Stage Nsclc ◽  
Time To Recurrence ◽  
Resected Nsclc

7547 Background: Surgical resection remains the standard curative treatment for early-stage NSCLC, but nearly 50% of p experience recurrence, highlighting the need for novel diagnostic and therapeutic strategies. Moreover, treatments in NSCLC are often histology-dependent, underlining the need for histology-related markers. MicroRNAs (miRNAs) are promising molecular markers in cancer, with marked differences in expression according to histology. miR-200 family members have been associated in vitro with the regulation of epithelial-mesenchymal transition. We have examined their impact on outcome in resected NSCLC p. Methods: We analyzed miRNA expression using TaqMan assays in 160 tumor samples from NSCLC p who had undergone surgical resection and correlated our findings with TTR and OS. Results: p characteristics: age, 67 (51-83); 140 male; 96 (60%) stage I, 34 (21.3%) stage II, 30 (18.7%) stage III; 77(48.1%) ADC, 71(44.4%) squamous cell carcinoma (SCC); 16 (9.1%) received adjuvant treatment. With a median follow-up of 28 months (m), 64 p (40%) had relapsed. TTR for the 107 p with high miR-200c was 26.7 m vs 100.2 m for the 52 p with low miR-200c (P=0.032). OS for p with high miR-200c was 71.2 m vs. 125 m for p with low miR-200c (P=0.01). TTR for 112 p with high miR-141 was 26.7 m vs. 100.2 m for 46 p with low miR-141 (P=0.06). OS for p with high miR-141 was 72 m vs. 118 m for p with low miR-141 (P=0.02). Interestingly, neither miR-200c nor miR-141 correlated with TTR or OS in SCC p. In contrast, in ADC p, the prognostic value of both miRNAs increased: miR-200c (TTR, P=0.01; OS, P<0.0001) and miR-141 (TTR, P=0.003; OS, P<0.0001). This prognostic value was maintained in the subgroup of stage I p: miR-200c (TTR, P=0.011; OS, P<0.001) and miR-141 (TTR, P=0.018; OS, P<0.001). In the multivariate analysis, miR-200c and miR-141 emerged as an independent prognostic factor for OS (OR: 3.2, P=0.006; OR:2.5, P=0.02, respectively) together with age>65 (OR: 3.3, P=0.001) and stage I (OR: 0.3, P=0.004). Conclusions: miR-200c and miR-141 expression is associated with TTR and OS in resected ADC but not in SCC NSCLC p.

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