Avelumab 800 mg in combination with pemetrexed / carboplatin for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carcinoma, Non-Small-Cell Lung+2 More
Avelumab 800 mg in combination with pemetrexed / carboplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing the safety and effectiveness of a new cancer drug, avelumab, when used in combination with chemotherapy. The trial will enroll patients with lung or bladder cancer who have not responded to other treatments.

Eligible Conditions
  • Carcinoma, Non-Small-Cell Lung
  • Urothelial Cancer
  • Non-small Cell Lung Cancer

Treatment Effectiveness

Study Objectives

4 Primary · 23 Secondary · Reporting Duration: From first dose of study drug up to last dose of study drug (maximum up to 3.5 years approximately)

Baseline
Mutational load within baseline tumor tissue
Day 8
PD-L1 expression in baseline and on-treatment tumor tissue
Day 21
Number of Participants With Programmed Death-Ligand 1 (PD-L1) Expression
Month 24
Confirmed objective response (OR)
Duration of Response (DR)
Progression-Free Survival (PFS)
Time to Tumor Response (TTR)
Day 8
Plasma
Plasma concentrations of cisplatin
Plasma concentrations of pemetrexed
Day 1
Plasma concentrations of gemcitabine
Week 6
Phase 1b Lead-in: Number of Participants With Dose-Limiting Toxicities (DLT)
Week 6
Phase 1b lead-in: Number of patients with dose-limiting toxicities in first 2 cycles
Year 5
Duration of Response (DOR) as Per RECIST v 1.1 by Investigator Assessment
Year 5
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies for Avelumab
Year 5
Overall Survival (OS)
Year 5
Time-to-Tumor Response (TTR) as Per RECIST v 1.1 by Investigator Assessment
Year 5
Number of Participants With Laboratory Abnormalities by CTCAE Grade
Year 5
Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment
Year 5
Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v 4.03
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Number of Participants With Treatment Related TEAEs
Year 5
Progression Free Survival (PFS) as Per RECIST v 1.1 by Investigator Assessment
Day 15
Serum
Day 1
Absolute Value of Tumor Mutational Burden (TMB) in Tumor Tissue
Day 1
Anti-Drug Antibody (ADA) levels of avelumab
Day 21
Serum Concentration of Avelumab

Trial Safety

Trial Design

4 Treatment Groups

Group A Cohort A2
1 of 4
Group A Cohort A3
1 of 4
Group A Cohort A1
1 of 4
Group A Cohort A4
1 of 4

Experimental Treatment

67 Total Participants · 4 Treatment Groups

Primary Treatment: Avelumab 800 mg in combination with pemetrexed / carboplatin · No Placebo Group · Phase 1 & 2

Group A Cohort A2
Drug
Experimental Group · 1 Intervention: Avelumab 800 mg in combination with gemcitabine / cisplatin. · Intervention Types: Drug
Group A Cohort A3
Drug
Experimental Group · 1 Intervention: Avelumab 1200 mg in combination with pemetrexed/carboplatin · Intervention Types: Drug
Group A Cohort A1
Drug
Experimental Group · 1 Intervention: Avelumab 800 mg in combination with pemetrexed / carboplatin · Intervention Types: Drug
Group A Cohort A4
Drug
Experimental Group · 1 Intervention: Avelumab 1200 mg in combination with gemcitabine/cisplatin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose of study drug up to last dose of study drug (maximum up to 3.5 years approximately)

Who is running the clinical trial?

PfizerLead Sponsor
4,264 Previous Clinical Trials
7,108,395 Total Patients Enrolled
106 Trials studying Carcinoma, Non-Small-Cell Lung
34,036 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,251 Previous Clinical Trials
4,823,875 Total Patients Enrolled
82 Trials studying Carcinoma, Non-Small-Cell Lung
18,692 Patients Enrolled for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a good performance status (PS) of 0 or 1.
Patients must have a TPS < 50% for PD L1 (via the 22C3 pharmDx or the Ventana (SP263) PD L1 IHC assay).
You have no prior systemic treatment for unresectable locally advanced or metastatic disease for the tumor type under study.
You have measurable disease by RECIST v1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.