NCT04325698|TerminatedPhase 3Results
Study Stopped
The study was terminated as part of the decision by Pfizer to halt its biosimilars programs in China.
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The study was terminated as part of the decision by Pfizer to halt its biosimilars programs in China.
A RANDOMIZED, DOUBLE-BLIND BRIDGING SAFETY AND EFFICACY STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF CHINESE PARTICIPANTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
Sponsor study identifier
interventional
8
1 country
4
Study Start
June 11, 2020
Actual (reported)Primary Completion
May 10, 2021
Actual (reported)Study Completion
May 10, 2021
Actual (reported)The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-06439535 (CN) in combination with paclitaxel and carboplatin versus bevacizumab sourced from the European Union (bevacizumab-EU) with paclitaxel and carboplatin in Chinese participants with advanced non-squamous NSCLC in the first-line treatment setting.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2019
Actual (reported)March 27, 2020
Actual (reported)June 11, 2020
Actual (reported)May 10, 2021
Actual (reported)May 10, 2021
Actual (reported)October 1, 2024
Actual (reported)Percentage of Participants Achieving Objective Response
Objective response referred to complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (non-progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions, normal nodes (target nodes must decrease to normal size); PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
From Week 1 to Week 25 (25 Weeks)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in Treatment Period
From Day 1 to end of Cycle 8; 1 Cycle = 21 Days
Number of Participants With Anti-Drug Antibodies (ADA)
Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 1 Cycle = 21 Days
Number of Participants With NAb
Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 1 Cycle = 21 Days
Trough and Apparent Peak PF-06439535 (CN) and Bevacizumab (EU) Concentrations
Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 2.5 hours after initiation of bevacizumab infusion on Day 1 of Cycle 1 and Cycle 5; 1 Cycle = 21 Days
Number of Participants With TEAEs in Extension Period
Cycle 9 Day 1 up to End of Treatment (up to Cycle 14 Day 21); 1 Cycle = 21 Days
PF-06439535 (CN) + paclitaxel + carboplatin
Bevacizumab-EU + paclitaxel + carboplatin
15 mg/kg, IV on day 1 of each 21 day cycle for up to 2 years, or until progression or unacceptable toxicity develops.
15 mg/kg, IV on day 1 of each 21 day cycle until disease progression, unacceptable toxicity or 25 weeks. At Week 25, the participants with clinical benefit will received PF-06439535 (CN) monotherapy for up to 2 years from randomization in this study
Dongguan People's Hospital
Dongguan, Guangdong, 523059, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The study was terminated on 17 March 2021 by the Sponsor. The decision to terminate this study was based on a business review of the biosimilars market and the Sponsor's global manufacturing network. This decision was not based on any safety or regulatory concerns with the treatment of participants with PF-06439535 (CN). The results reported are limited to safety, PK and immunogenicity, and only safety is summarized.
Pfizer CT.gov Call Center
Pfizer
8 participants (actual enrollment reported by the registry).
First Submitted
October 14, 2019
First Posted
March 27, 2020
Study Start
June 11, 2020
Actual (reported)175 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.
AUC 5 (max=750mg) via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 10, 2021
Actual (reported)Study Completion
May 10, 2021
Actual (reported)Last Updated
October 1, 2024
Results First Posted
October 1, 2024
Record last verified: 2024-06
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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