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Report for Clinical Trial NCT03840915
Developed by Shray Alag, 2020-2021.
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 ---