A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Advanced Non-squamous NSCLC

Treatments: Drug: PF-06439535 (CN); Drug: Carboplatin; Drug: Bevacizumab-EU; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04325698

B7391007

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

Arm A

Experimental group

Description:

PF-06439535 (CN) + paclitaxel + carboplatin

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: PF-06439535 (CN)

Arm B

Active Comparator group

Description:

Bevacizumab-EU + paclitaxel + carboplatin

Treatment:

Drug: Paclitaxel

Drug: Bevacizumab-EU

Drug: Carboplatin