AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Conditions

LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Brief summary

Overall survival, PFS using RECIST v1.1 as assessed by BICR

Detailed description

1. Key - Confirmed ORR using RECIST v1.1 as assessed by BICR, 2. PFS using RECIST v1.1 as assessed by investigator; Confirmed ORR using RECIST v1.1 as assessed by investigator; DoR using RECIST v1.1 as assessed by BICR; DoR using RECIST v1.1 as assessed by investigator, 3. AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s); Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing., 4. Predose and postdose concentrations of PF-08634404., 5. Incidence of ADA against PF-08634404, 6. Change from baseline in the global health status/QoL, and Physical function scores on the EORTC QLQ-C30; Change from baseline in dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13; Time to definitive deterioration in the global health status/QoL and physical function scores on the EORTC QLQ-C30; Time to definitive deterioration in dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPEMETREXED

DRUGPF-08634404

DRUGPACLITAXEL

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGPEMBROLIZUMAB

DRUGCARBOPLATIN

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival, PFS using RECIST v1.1 as assessed by BICR	—

Secondary

Measure	Time frame
1. Key - Confirmed ORR using RECIST v1.1 as assessed by BICR, 2. PFS using RECIST v1.1 as assessed by investigator; Confirmed ORR using RECIST v1.1 as assessed by investigator; DoR using RECIST v1.1 as assessed by BICR; DoR using RECIST v1.1 as assessed by investigator, 3. AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s); Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing., 4. Predose and postdose concentrations of PF-08634404., 5. Incidence of ADA against PF-08634404, 6. Change from baseline in the global health status/QoL, and Physical function scores on the EORTC QLQ-C30; Change from baseline in dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13; Time to definitive deterioration in the global health status/QoL and physical function scores on the EORTC QLQ-C30; Time to definitive deterioration in dyspnea	—

Measure

Time frame

1. Key - Confirmed ORR using RECIST v1.1 as assessed by BICR, 2. PFS using RECIST v1.1 as assessed by investigator; Confirmed ORR using RECIST v1.1 as assessed by investigator; DoR using RECIST v1.1 as assessed by BICR; DoR using RECIST v1.1 as assessed by investigator, 3. AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s); Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing., 4. Predose and postdose concentrations of PF-08634404., 5. Incidence of ADA against PF-08634404, 6. Change from baseline in the global health status/QoL, and Physical function scores on the EORTC QLQ-C30; Change from baseline in dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13; Time to definitive deterioration in the global health status/QoL and physical function scores on the EORTC QLQ-C30; Time to definitive deterioration in dyspnea

—

Outcome results

None listed