A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients with Resectable Stage I-III Non-Small Cell Lung Cancer, selected according to Biomarker Status

Conditions

Resectable Stage I-III Non-Small Cell Lung Cancer (NSCLC)

Brief summary

1. Cohort B1: Incidence, type, and severity of adverse events with onset up to 28 days after the last dose of chemotherapy treatment according to NCI CTCAE v5.0., 2. Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)

Detailed description

1. Cohort B1:Investigator-assessed disease-free survival (DFS), 2. Cohort B1:Disease-free rates at 1, 2, 3, 4, and 5 years, 3. Cohort B1: Overall survival (OS), 4. Cohort B1:Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0). Adverse Events with onset up to 28 days after the last dose of study treatment, 5. Cohort B1: Time to first onset of selected Adverse Events, 6. Cohort B1:Change from baseline in target safety parameters (vital signs, clinical laboratory test results, ECG parameters). Baseline will be defined as the last assessment prior to first treatment, 7. Cohort B2:Investigator-assessed major pathological response (inv-MPR), 8. Cohort B2: Pathologic complete response (pCR) by independent review, 9. Cohort B2: Major pathologic response (MPR) by independent review, 10. Cohort B2: Investigator-assessed overall response rate (ORR) per RECIST v1.1, 11. Cohort B2: Investigator-assessed event-free survival (EFS), 12. Cohort B2: OS, 13. Cohort B2: Incidence, severity and type of AEs, with severity determined through use of NCI CTCAE v5.0, 14. Cohort B2: Change from baseline in target safety parameters (vital signs, clinical laboratory test results, ECG parameters), 15. Cohort B2: Frequency of surgery completion, defined as patients who have successfully completed surgery without treatment related delays (> 60 days) from the last dose of neoadjuvant treatment, 16. Cohort B2: Length of treatment related surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations

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Interventions

DRUGCisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

DRUGCisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGAlectinib (Alecensa)

DRUGAlecensa 150 mg hard capsules

DRUGPemetrexed Pfizer 25 mg/ml concentrate for solution for infusion.

DRUGCARBOPLATINE ACCORD 10 mg/ml

DRUGsolution pour perfusion

DRUGCISPLATINE ACCORD 1 mg/ml

DRUGsolution à diluer pour perfusion

DRUGPemetrexed Accord 25 mg/ml concentrate for solution for infusion

DRUGCarboplatin Bendalis 10mg/ml

DRUGKonzentrat zur Herstellung einer Infusionslösung

DRUGPEMETREXED

DRUGCARBO-cell® 10 mg/ml Infusionslösung

DRUGPemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion

DRUGCarboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Cohort B1: Incidence, type, and severity of adverse events with onset up to 28 days after the last dose of chemotherapy treatment according to NCI CTCAE v5.0., 2. Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)	—

Secondary

Measure	Time frame
1. Cohort B1:Investigator-assessed disease-free survival (DFS), 2. Cohort B1:Disease-free rates at 1, 2, 3, 4, and 5 years, 3. Cohort B1: Overall survival (OS), 4. Cohort B1:Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0). Adverse Events with onset up to 28 days after the last dose of study treatment, 5. Cohort B1: Time to first onset of selected Adverse Events, 6. Cohort B1:Change from baseline in target safety parameters (vital signs, clinical laboratory test results, ECG parameters). Baseline will be defined as the last assessment prior to first treatment, 7. Cohort B2:Investigator-assessed major pathological response (inv-MPR), 8. Cohort B2: Pathologic complete response (pCR) by independent review, 9. Cohort B2: Major pathologic response (MPR) by independent review, 10. Cohort B2: Investigator-assessed overall response rate (ORR) per RECIST v1.1, 11. Cohort B2: Investig	—

Measure

Time frame

1. Cohort B1:Investigator-assessed disease-free survival (DFS), 2. Cohort B1:Disease-free rates at 1, 2, 3, 4, and 5 years, 3. Cohort B1: Overall survival (OS), 4. Cohort B1:Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0). Adverse Events with onset up to 28 days after the last dose of study treatment, 5. Cohort B1: Time to first onset of selected Adverse Events, 6. Cohort B1:Change from baseline in target safety parameters (vital signs, clinical laboratory test results, ECG parameters). Baseline will be defined as the last assessment prior to first treatment, 7. Cohort B2:Investigator-assessed major pathological response (inv-MPR), 8. Cohort B2: Pathologic complete response (pCR) by independent review, 9. Cohort B2: Major pathologic response (MPR) by independent review, 10. Cohort B2: Investigator-assessed overall response rate (ORR) per RECIST v1.1, 11. Cohort B2: Investig

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Countries

Austria, Belgium, Denmark, France, Italy, Netherlands, Poland, Spain

Outcome results

None listed