Clinical trial · Interventional
Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
- 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)
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Carboplatin + pemetrexed + bevacizumab
- interventionNames
- Biological: bevacizumab
- Drug: carboplatin
- Drug: pemetrexed
Primary outcomes (1)
- measure
- Median Progression Free Survival
- timeFrame
- Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)
- description
- Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically\* or cytologically\* confirmed non-small cell lung cancer
* Any histology, except squamous cell carcinoma, allowed
* Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible
* No histology in close proximity to a major vessel or cavitation NOTE: \*Histologic or cytologic elements may be established on metastatic tumor aspirates or biopsy
* Meets 1 of the following stage criteria:
* Stage IIIB disease (with malignant pleural effusion)
* Stage IV disease
* Recurrent disease
* Measurable or non-measurable disease
* No known CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* No history of hemorrhagic disorders
Hepatic
* Bilirubin \< 1.5 mg/dL
* AST and ALT \< 5 times upper limit of normal
* INR \< 1.5
* PTT normal
Renal
* Creatinine clearance ≥ 45 mL/min
* Urine protein:creatinine ≤ 1.0 by spot urinalysis
Cardiovascular
* No myocardial infarction within the past 6 months
* No New York Heart Association class II-IV congestive heart failure
* No unstable angina pectoris
* No serious cardiac arrhythmia requiring medication
* No stroke within the past 6 months
* No peripheral vascular disease ≥ grade 2
* No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)
* Patients with a history of hypertension allowed provided blood pressure is well controlled on a stable regimen of anti-hypertensive therapy
* No history of thrombotic disorders
* No other clinically significant cardiovascular disease
Pulmonary
* No history of gross hemoptysis, defined as bright red blood of a ½ teaspoon or more
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be willing and able to take daily oral folic acid, intermittent vitamin B\_12 injections, and corticosteroid premedication
* No ongoing or active infection
* No serious, non-healing wound, ulcer, or bone fracture
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 3 weeks since prior immunotherapy
Chemotherapy
* No prior systemic chemotherapy
Endocrine therapy
* More than 3 weeks since prior hormonal therapy
Radiotherapy
* See Disease Characteristics
* More than 3 weeks since prior radiotherapy
Surgery
* More than 4 weeks since prior major surgery
* More than 1 week since prior minor surgery, fine needle aspiration, or core biopsy
* No concurrent major surgery
Other
* Recovered from all prior therapy
* More than 4 weeks since prior and no concurrent participation in another experimental drug study
* No aspirin or other nonsteroidal anti-inflammatory drug (NSAID) 2 days before and 2 days after each pemetrexed disodium infusion (5 days before and 2 days after each pemetrexed disodium infusion for NSAIDs with a long half-life \[e.g., naproxen, rofecoxib, or celecoxib\])
* No concurrent therapeutic anticoagulation
* Concurrent prophylactic anticoagulation for venous access devices allowed provided requirements for INR and PTT are met
* No concurrent administration of any of the following:
* Chronic daily treatment with aspirin (\> 325 mg per day)
* NSAIDs known to inhibit platelet function, including any of the following:
* Dipyridamole
* Ticlopidine
* Clopidogrel
* CilostazolReferences
Publications (0)
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