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NCT02879097
Efficacy, Safety & Immunogenicity Study of CBT124 & EU-sourced Avastin® in Combination With Carboplatin and Paclitaxel in First-line Treatment in (NSCLC)
Phase 3 trial testing CBT124 in Non-Small Cell Lung Carcinoma in 200 participants. Status unknown.
1 December 2017
Quick facts
| Lead sponsor | Cipla BioTec Pvt. Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 December 2016 |
| Primary completion | 1 December 2017 |
| Estimated completion | 1 May 2018 |
Drugs / interventions tested
- CBT124 — full drug profile →
- EU-sourced Avastin® — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Non-Small Cell Lung Carcinoma — all drugs for Non-Small Cell Lung Carcinoma →
Sponsor
Cipla BioTec Pvt. Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Non-Small Cell Lung Carcinoma. 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)
Time frame: 19 weeks
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1). Defined as the proportion of subjects whose best confirmed overall response over Week 1 to Week 19 is either Complete Response (CR) or Partial Response (PR). Confirmed best overall response (complete or partial response) may be claimed only if the criteria for each are met after a repea
Sponsor's own description
The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that of Avastin® (pharmacokinetics is nested in this study for Indian patients).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Monoclonal antibody biosimilars for cancer treatment.
Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115 -
Biosimilar monoclonal antibodies for cancer treatment in adults.
Galvao TF, Livinalli A, Lopes LC, Zimmermann IR, et al · · 2024 · cited 2× · PMID 39607013 · DOI 10.1002/14651858.cd013539.pub2
Verify or expand the search:
- PubMed search for NCT02879097
- 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 NCT02879097 (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 Cipla BioTec Pvt. Ltd.
- Last refreshed: 22 August 2016
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/NCT02879097.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing