A Phase 3 Randomized, Double-Blind Study of PF-06439535 plus Paclitaxel-Carboplatin and Bevacizumab plus Pacitaxel-Carboplatin for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer.

Not Applicable

• Conditions: -C34 Malignant neoplasm of bronchus and lung; Malignant neoplasm of bronchus and lung; C34

• Registration Number: PER-029-15
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patient eligibility should be reviewed and documented by an appropriate member of the investigator’s study team before patients are included in the study.
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the
study:
1. Male and female patients age ≥18 years of age, or ≥ age of consent in the region.
2. Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC) for which they had not received chemotherapy for metastatic disease.
3. Histologically or cytologically confirmed diagnosis of predominately non-squamous
NSCLC.
4. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). ...(See Printed Dossier)

Exclusion Criteria

Patients presenting with any of the following will not be included in the study:
1. Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
2. Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation.
3. Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
4. History of other cancer within 5 years prior to screening for this study, with the exception of adequately treated ductal carcinoma in situ of the breast, cervical carcinoma in situ, or basal or squamous cell skin cancer.
5. Prior systemic therapy for metastatic disease. ...(See Printed Dossier)

Study & Design

• Study Type: Interventional
• Study Design: Not specified