Lecture on update on clinical trial @ AATS International Thoracic Surgical Oncology Summit, NYC October 2018
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An overview of the most relevant ongoing trials in Thoracic Surgical Oncology by Dr. Alex Brunelli. There is a need for high quality surgery delivered in the context of multimodal treatment of lung cancer
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Lecture on update on clinical trial @ AATS International Thoracic Surgical Oncology Summit, NYC October 2018
- 3. Harry J. de Koning, Erasmus MC, Public Health Rotterdam Males: 26% reduction of risk of dying of lung cancer Females: up to 39% reduction of risk of dying of lung cancer
- 7. 7 Patient population: Multicenter, Global, Phase III, RCT, 2 groups assignment Resectable Stage II, IIIA, or select IIIB (T3N2) NSCLC • Patient group that would typically receive neoadjuvant or adjuvant chemotherapy • Must be eligible for an R0 resection at screening as evaluated by the attending thoracic surgeon • All-comer population regardless of PDL-1 status
- 8. 8 GO40241 Phase III randomized, double-blind, placebo-controlled study (Neoadjuvant early stage resectable NSCLC) Double Blinded Unblinded Survival Follow-up Surgery and pathological response assessment (MPR, pCR) Placebo + Platinum-based chemotherapy Q3W x 4 cycles Arm B: Best Supportive Care and Observational Follow-up Arm B: Resectable Stage II, IIIA, or select IIIB (T3N2) NSCLC ECOG PS 0–1 ALK-/EGFR- (NSQ only) N=302 Stratification • II vs. IIIA N2- vs. IIIA/B N2+ • Pemetrexed vs. Nab-Pac R 1:1 Platinum-based chemotherapy options: Non-squamous i. Cisplatin + Pemetrexed ii. Carboplatin + Pemetrexed iii. Carboplatin + Nab-Paclitaxel Squamous i. Carboplatin + Nab-Paclitaxel Atezolizumab + Platinum-based chemotherapy Q3W x 4 cycles Arm A: Atezolizumab Q3W x 16 cycles Arm A: Note: PORT required for patients with N2+ disease at resection or positive margins prior to initiating post-operative atezo or BSC
- 9. 9 Primary Efficacy Objective Primary Outcome Measure • Major Pathological Response (MPR) defined as ≦ 10% viable tumor tissue from the primary tumor
- 10. 10 Surrogate endpoint in induction treatment trials: pathologic response rate (% viable cancer cells) Pataer A et al JTO 2012; 7: 825-832
- 11. 11 Additional Efficacy Objectives Secondary Outcome Measures • Investigator assessed EFS, OS, ORR, DFS, pCR • Centrally assessed pCR • HRQoL scores: Changes from baseline score in by cycle and between treatment arms during the neoadjuvant treatment phase, and during the post-surgery adjuvant treatment phase
- 12. 12 Estimated enrollment 302 patients Estimated Study completion Date: November 2024 Estimated completion date for primary outcome: March 2020 Recruitment and Completion * Additional PRO data will be collected as Exploratory Efficacy Objectives (To be covered by Agnes Hong)
- 14. 14 Patient population: Multicenter, North America, Single Group Assignment Resectable Stage Ib, II, IIIA, or select IIIB (T3N2) NSCLC • 2 cycles of Ate > Surgery, • 12 months of adjuvant Ate
- 15. 15 Primary Efficacy Objective Primary Outcome Measure • Major Pathological Response (MPR) defined as ≦ 10% viable tumor tissue from the primary tumor
- 16. 16 Estimated enrollment 180 patients Estimated Study completion Date: Oct 2024 Estimated completion date for primary outcome: Feb 2020 Recruitment and Completion
- 17. 17 Initial report on the first 54 patients 50 patients underwent resection after Ate treatment MPR rate was 20% In PDL-1 + patients MPR was 29% Initial Results- Presented at WCLC 2018 Toronto
- 19. 19 Patient population: MultiCenter RCT, Global, 3 Groups Assignment Resectable Stage Ib, II, IIIA NSCLC • Group 1: Nivolumab + Ipilumab + Surgery • Group 2: Nivolumab + Chemotherapy + surgery • Group 3: Chemotherapy + surgery
- 20. 20 Primary Efficacy Objective Primary Outcome Measure • Event Free Survival • Pathological Complete Response Secondary Outcome Measure • OS • MPR
- 21. 21 Estimated enrollment 642 patients Estimated Study completion Date: Nov 2028 Estimated completion date for primary outcome: May 2023 Recruitment and Completion
- 23. 23 Patient population: MultiCenter, RCT, Global, 2 Groups Assignment Resectable Stage IIb, IIIA NSCLC • Group 1: neoadjuvant chemotherapy + Pembrolizumab + Surgery + adjuvant Pembrolizumab • Group 2: neoadjuvant chemotherapy + placebo + surgery + adjuvant placebo
- 24. 24 Primary Efficacy Objective Primary Outcome Measure • Event Free Survival • Overall Survival
- 25. 25 Estimated enrollment 786 patients Estimated Study completion Date: June 2026 Estimated completion date for primary outcome: January 2024 Recruitment and Completion
- 28. 28 Patient population: MultiCenter, Global Investigation, Randomized 2 Groups Assignment Resected Stage Ib, II, IIIA NSCLC • Primary Surgery with or without adjuvant chemotherapy • Group 1: Pembrolizumab every 3 weeks for 12 months • Group 2: Placebo every 3 weeks for 12 months
- 29. 29 Primary Efficacy Objective Primary Outcome Measure • Disease Free Survival
- 30. 30 Estimated enrollment 1380 patients Estimated Study completion Date: August 2021 Estimated completion date for primary outcome: August 2021 Recruitment and Completion
- 32. 32 Patient population: MultiCenter, Global Investigation, Randomized 2 Groups Assignment Resected Stage Ib, II, IIIA NSCLC • Primary Surgery with or without adjuvant chemotherapy • Group 1: Dorvalumab from day 1 for 12 months (with or without additional chemotherapy) • Group 2: Placebo from day 1 for 12 months
- 33. 33 Primary Efficacy Objective Primary Outcome Measure • Disease Free Survival in PDL-1 positive patients • DFS in all randomized patients
- 34. 34 Estimated enrollment 1360 patients Estimated completion date for primary outcome: January 2023 Recruitment and Completion
- 36. 36 Patient population: NCI, ECOG-ACRIN RESEARCH GROUP, Randomized, Phase III 2 Groups Assignment Resected Stage Ib, II, IIIA NSCLC • Primary Surgery • Group 1: NIVOLUMAB for up to 1 year and standard chemotherapy • Group 2: standard chemotherapy + no additional intervention
- 37. 37 Primary Efficacy Objective Primary Outcome Measure • Overall survival • Disease Free Survival
- 38. 38 Estimated enrollment 714 patients Estimated completion date for primary outcome: July 2024 Recruitment and Completion
- 40. 40 Patient population: MultiCenter, global, Randomized, Phase III 2 Groups Assignment Resected Stage Ib, II, IIIA NSCLC • Primary Surgery with adjuvant chemotherapy> randomized • Group 1: Atezolizumab 16 cycles • Group 2: best supportive care
- 41. 41 Primary Efficacy Objective Primary Outcome Measure • Disease free survival
- 42. 42 Estimated enrollment 1127 patients Estimated completion date for primary outcome: Sept 2026 Estimated study completion date: Sept 2026 Recruitment and Completion
- 44. A Phase III Randomized Trial of Lobectomy versus Segmentectomy for Lung Cancer (JCOG0802/WJOG4607L)
- 45. 45 Patient population: Phase III, randomized, multicenter Stage Ia, Ib <2 cm Peripheral C/T ratio <0.5 NSCLC • Intentional segmentectomy vs. lobectomy
- 46. 46 Primary Efficacy Objective Primary Outcome Measure • Non inferiority study on Overall survival
- 47. 47 Recruitment completed of 1100 patients Estimated completion date for primary outcome: 2020 Recruitment and Completion
- 49. 49 Patient population: Phase III, randomized, multicenter Stage Ia, Ib <2 cm Peripheral NSCLC • Intentional segmentectomy and wedge vs. lobectomy
- 50. 50 Primary Efficacy Objective Primary Outcome Measure • Non inferiority study on Disease Free survival
- 51. 51 Recruitment completed of 701 patients Estimated completion date for primary outcome: March 2021 Recruitment and Completion
- 54. 54 Patient population:Feasibility study, randomized, multicenter (5 units), UK Stage T1-T2bN0 Peripheral High risk patients NSCLC • High risk estimated by the multidisciplinary team consensus using several parameters including PFTs, exercise test, and risk scores • Eligible patients were approached by a respiratory physician and randomised 1:1 • SABR vs Surgery (any extent)
- 55. 55 Primary Efficacy Objective Primary Outcome Measure • Recruitment rate of > 3 per month from 5 centers to inform feasibility of a large scale RCT
- 56. 56 Results Final recruitment rate was 1.7 per month The main reason for declining the study was patient preference with 29% preferring surgery and 42% SABR. Overall 9/24 (38%) did not receive their randomised treatment. CONCLUSIONS: Conducting a large RCT in the UK was shown not to be feasible.