Status:
TERMINATED
A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC
Lead Sponsor:
Pfizer
Conditions:
Advanced Non-squamous NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Male and female participants age at least 18 years of age.
- Newly diagnosed Stage IIIB, IIIC or IV non small cell lung cancer (NSCLC) (according to American Joint Committee on Cancer (AJCC) Staging Manual, 8th Edition, last updated 05 June 2018) or recurrent NSCLC.
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
- At least one measurable lesion as defined by RECIST v1.1.
- Be eligible to receive bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.
Exclusion
- Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas.
- Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that, in the opinion of the investigator, is likely to bleed.
- Known EGFR activating mutations (for example, exon 19 deletion or exon 21 L858R substitution mutations) or ALK rearrangements.
- Prior systemic therapy for advanced NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04325698
Start Date
June 11 2020
End Date
May 10 2021
Last Update
October 1 2024
Active Locations (4)
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1
Dongguan People's Hospital
Dongguan, Guangdong, China, 523059
2
Affiliated Hospital of Hebei University
Baoding, Hebei, China, 071000
3
Jinan Central Hospital
Jinan, Shandong, China, 250013
4
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052