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NCT02364999
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.
Phase 3 trial testing Bevacizumab-Pfizer in Non-Small Cell Lung Cancer in 719 participants. Completed in 1 December 2017.
1 May 2017
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 719 |
| Start date | 1 April 2015 |
| Primary completion | 1 May 2017 |
| Estimated completion | 1 December 2017 |
| Sites | 263 locations across United States, Australia, Brazil, Bulgaria, Chile, Croatia, Czechia, France |
Drugs / interventions tested
- Bevacizumab-Pfizer — full drug profile →
- Bevacizumab-EU (bevacizumab-eu) — full drug profile →
- Paclitaxel — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
Conditions studied
- Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
Sponsor
Pfizer — full company profile →
Who can join
18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Objective Response Rate (ORR) by Week 19
Time frame: 25 weeks
ORR refers to percentage of participants who achieved 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-targ
Sponsor's own description
This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars.
Rosen LS, Jacobs IA, Burkes RL. · · 2017 · cited 114× · PMID 28801849 · DOI 10.1007/s11523-017-0518-1 -
State of the art in anti-cancer mAbs.
Chiavenna SM, Jaworski JP, Vendrell A. · · 2017 · cited 52× · PMID 28219375 · DOI 10.1186/s12929-016-0311-y -
PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin<sup>®</sup>), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study.
Reinmuth N, Bryl M, Bondarenko I, Syrigos K, et al · · 2019 · cited 40× · PMID 31338773 · DOI 10.1007/s40259-019-00363-4 -
A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers.
Knight B, Rassam D, Liao S, Ewesuedo R. · · 2016 · cited 33× · PMID 26984210 · DOI 10.1007/s00280-016-3001-2 -
Does Biosimilar Bevacizumab Offer Affordable Treatment Options for Cancer Patients in the USA? A Budget Impact Analysis from US Commercial and Medicare Payer Perspectives.
Yang J, Liu R, Ektare V, Stephens J, et al · · 2021 · cited 17× · PMID 33506318 · DOI 10.1007/s40258-021-00637-5 -
Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review.
Chan SHY, Khatib Y, Webley S, Layton D, et al · · 2023 · cited 10× · PMID 37383708 · DOI 10.3389/fphar.2023.1137983 -
Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin<sup>®</sup>) in patients with advanced non-squamous non-small cell lung cancer.
Li CSW, Sweeney K, Cronenberger C. · · 2020 · cited 10× · PMID 31768697 · DOI 10.1007/s00280-019-03946-8 -
Efficacy and Safety of Bevacizumab Biosimilars Compared With Reference Biologics in Advanced Non-small Cell Lung Cancer or Metastatic Colorectal Cancer Patients: A Network Meta-Analysis.
Xu X, Zhang S, Xu T, Zhan M, et al · · 2022 · cited 8× · PMID 35865968 · DOI 10.3389/fphar.2022.880090
Verify or expand the search:
- PubMed search for NCT02364999
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02364999 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 18 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02364999.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing