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Report for Clinical Trial NCT03840915
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The main purpose of the study is to evaluate the safety and tolerability of M7824 in
combination with chemotherapy.
Name: Cisplatin
Description: Cisplatin will be administered intravenously at a dose of 75 milligrams per meter square (mg/m^2) over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
Type: Drug
Group Labels: 2 Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824 Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824
Name: Carboplatin
Description: Carboplatin will be administered at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
Type: Drug
Group Labels: 1 Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824
Name: Pemetrexed
Description: Pemetrexed will be administered intravenously at a dose of 500 mg/ m^2 over 10 minutes every 21 days.
Type: Drug
Group Labels: 1 Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824
Name: Nab-paclitaxel
Description: Nab-paclitaxel will be administered intravenously at as dose of 100 mg/m^2 over 30 minutes in a 21 days cycle on Day 1, 8, and 15 in each cycle for 4 cycles (each cycle is 21 days).
Type: Drug
Group Labels: 1 Cohort B: Carboplatin + Paclitaxel or Nab-paclitaxel + M7824
Name: Gemcitabine
Description: Gemcitabine will be administered intravenously at a dose of 1250 mg/m^2 over 30 minutes in a 21 days cycle on Day 1, and 8, in each cycle for 4 cycles (each cycle is 21 days).
Type: Drug
Group Labels: 1 Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824
Name: Docetaxel
Description: Docetaxel will be administered intravenously at a dose of 75 mg/m^2 over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
Type: Drug
Group Labels: 1 Cohort D: Docetaxel + M7824
Name: M7824
Description: M7824 will be administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 and pemetrexed.
Type: Drug
Group Labels: 1 Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824
Name: Carboplatin
Description: Carboplatin will be administered at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
Type: Drug
Group Labels: 1 Cohort B: Carboplatin + Paclitaxel or Nab-paclitaxel + M7824
Name: Carboplatin
Description: Carboplatin will be administered at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
Type: Drug
Group Labels: 1 Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824
Name: M7824
Description: M7824 will be administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 alone.
Type: Drug
Group Labels: 3 Cohort B: Carboplatin + Paclitaxel or Nab-paclitaxel + M7824 Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824 Cohort D: Docetaxel + M7824
Name: Paclitaxel
Description: Paclitaxel will be administered intravenously at a dose of 200 mg/m2 over 3 hours every 3 weeks for 4 cycles (each cycle is 21 days).
Type: Drug
Group Labels: 1 Cohort B: Carboplatin + Paclitaxel or Nab-paclitaxel + M7824
Primary Outcomes
Measure: Incidence of Dose Limiting Toxicities (DLTs) Time: Day 1 to Day 21 (Cycle 1)
Measure: Incidence of Treatment Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events Time: Up to 3 years
Secondary Outcomes
Measure: Confirmed Objective Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 Time: Up to 3 years
Measure: Progression-Free Survival (PFS) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 Time: Up to 3 years
Measure: Overall Survival (OS) Time: Up to 3 years
Measure: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 Time: Up to 3 years
Measure: Concentration of M7824 Observed Immediately at the End of Infusion (Ceoi) Time: Up to 3 years
Measure: Concentration of M7824 Observed Immediately Before Next Dosing (Ctrough) Time: Up to 3 years
Measure: Area Under the Serum Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of M7824 Time: Up to 3 years
Measure: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of M7824 Time: Up to 3 years
Measure: Maximum Observed Serum Concentration (Cmax) of M7824 Time: Up to 3 years
Measure: Time to Reach Maximum Serum Concentration (Tmax) of M7824 Time: Up to 3 years
Measure: Apparent Terminal Half-life (t1/2) of M7824 Time: Up to 3 years
Measure: Immunogenicity of M7824, as Assessed by Anti-drug Anti-body (ADA) Assay Time: Up to 3 years
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
1 V600E
Fresh biopsies should be collected if archived tumor material is not
available
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study
entry and date of first dose
Exclusion Criteria:
- The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing
(activating) mutation,ROS1 rearrangement, or BRAF V600E mutation or anaplastic
lymphoma kinase (ALK) positive, if targeted therapy is locally approved
- Mixed small cell with NSCLC cancer histology
- Has received major surgery within 4 weeks prior to the first dose of study
intervention; received thoracic radiation therapy (RT) of > 30 gray (Gy) within 6
months prior to the first dose of study intervention
- Previous malignant disease (other than the target malignancy to be investigated in
this study) within the last 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. --- V600E ---
HPO Nodes
HPO: