Clinical trial · Interventional
Study of Participants With Advanced Non-Small Cell Lung Cancer
A Study of Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed vs Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced NCSLC of Nonsquamous Histology
NCT00948675CI-TRIAL-00054745completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in participants with Stage IV nonsquamous non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Biological | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pemetrexed + Carboplatin + Pemetrexed
- description
- Pemetrexed and Carboplatin followed by Pemetrexed
- interventionNames
- Drug: Pemetrexed
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel + Carboplatin + Bevacizumab
- description
- Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab
- interventionNames
- Drug: Carboplatin
- Drug: Paclitaxel
- Biological: Bevacizumab
Primary outcomes (1)
- measure
- Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * a histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC) \[Stage IV from the American Joint Committee on Cancer Staging Criteria (AJCC) staging system, version 7.0, including both M1a and M1b\], other than predominantly squamous cell histology, that is not amenable to curative therapy. Participants may not have received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy, including adjuvant therapy, for any stage of NSCLC. * prior radiation therapy is allowed to \< 25% of the bone marrow; however, prior radiation to the whole pelvis not allowed. * good performance status. * adequate organ function. * estimated life expectancy of at least 12 weeks. Exclusion Criteria: * known central nervous system (CNS) disease, other than treated brain metastasis. * major surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days prior to study or have an anticipated need for major surgery during the study. * core biopsy or other minor surgical procedure, excluding placement of vascular access device, closed pleurodesis, thoracentesis, and mediastinoscopy, within 7 days prior to study. * history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis. * currently receiving ongoing treatment with full-dose warfarin or equivalent * significant vascular disease within 6 months prior to Day 1 of Cycle 1. * evidence of bleeding diathesis or coagulopathy. * serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol. * serious cardiac condition, such as myocardial infarction, angina, or heart disease. * inadequately controlled hypertension. * any prior history of hypertensive crisis or hypertensive encephalopathy. * serious, nonhealing wound, active ulcer, or untreated bone fracture. * another active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years. * previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab (prior intravitreal administration of bevacizumab does not preclude study participation). * pregnant or breast-feeding. * history of stroke or transient ischemic attack within 6 months prior to study. * known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab. * history of hemoptysis within 3 months prior to randomization. * unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). * unwilling to take folic acid or vitamin B12 supplementation. * clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage. Participants with M1a disease with pleural effusions are eligible if the effusions can be adequately controlled.
References
Publications (1)
- DERIVEDZinner RG, Obasaju CK, Spigel DR, Weaver RW, Beck JT, Waterhouse DM, Modiano MR, Hrinczenko B, Nikolinakos PG, Liu J, Koustenis AG, Winfree KB, Melemed SA, Guba SC, Ortuzar WI, Desaiah D, Treat JA, Govindan R, Ross HJ. PRONOUNCE: randomized, open-label, phase III study of first-line pemetrexed + carboplatin followed by maintenance pemetrexed versus paclitaxel + carboplatin + bevacizumab followed by maintenance bevacizumab in patients ith advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Jan;10(1):134-42. doi: 10.1097/JTO.0000000000000366. PMID 25371077