Actively Recruiting
Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC
Led by Fox Chase Cancer Center · Updated on 2025-04-16
117
Participants Needed
1
Research Sites
434 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
N
National Comprehensive Cancer Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
While cigarette smoking remains the primary cause of most lung cancer cases, lung carcinoma in never smokers account for nearly 20 percent of cases. Never smokers with lung cancer typically present with different molecular profiles from that of smokers, which results in prognostic and therapeutic implications. Molecular changes in NSCLC that have therapeutic significance include mutations in the epidermal growth factor receptor (EGFR) and rearrangements in the anaplastic lymphoma kinase (ALK) gene. These driver mutations typically are present in lung tumors found in never or light smokers. The addition of bevacizumab to carboplatin and paclitaxel in first-line treatment of non-squamous NSCLC showed improved survival compared to carboplatin and paclitaxel alone, 12.3 vs. 10.3 months respectively. Results from the POINTBREAK trial demonstrated that carboplatin + pemetrexed + bevacizumab is an alternative option to carboplatin + paclitaxel + bevacizumab, with comparable survival but less toxicity. In recent years, immunotherapy has emerged as a form of treatment that can lead to robust responses in a subset of patients. The PD-1 inhibitor nivolumab and the PD-L1 inhibitor atezolizumab have shown prolonged survival in comparison to docetaxel in patients who previously progressed with chemotherapy, irrespective of PD-L1 expression. Thus, this study combines immunotherapeutic agent atezolozumab with an ant-angiogenic agent, bevacizumab, and double platinum therapy (carboplatin and pemetrexed).
CONDITIONS
Official Title
Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed stage IV non-squamous non-small cell lung cancer
- Tumors must have EGFR mutation in exon 19 or 21, or be from never smokers without ALK or ROS1 rearrangements
- Measurable disease by CT or MRI according to RECIST v1.1
- EGFR exon 19 or 21 mutation patients must have prior TKI treatment with at least 3 days washout
- Never smoker wild-type patients must be treatment naive
- Chemotherapy, anti-VEGF therapy, and immunotherapy naive except prior oral TKIs for EGFR mutated patients
- History of treated asymptomatic brain metastases meeting specific criteria
- Completed curative intent therapy over 1 year before trial entry
- Age over 18 years
- ECOG performance status of 0 or 1
- Normal organ and marrow function as defined in protocol
- Stable full-dose anticoagulation if applicable
- Able and willing to provide informed consent
- Available biopsy sample or agree to fresh biopsy before treatment
- Urinary protein less than or equal to 1+ on dipstick or less than 1000 mg/24hr if higher
- Females of childbearing potential must agree to use effective contraception during and at least 6 months after treatment
- Males with partners of childbearing potential must agree to use effective contraception during and 8 months after treatment
You will not qualify if you...
- Currently receiving other investigational, immunomodulatory agents, chemotherapy, or TKIs (except prior TKI for EGFR mutation-positive patients)
- Grade 3-4 gastrointestinal bleeding within 3 months prior to treatment
- Untreated brain metastases larger than 1 cm
- Severe cirrhosis or history of hepatic encephalopathy or significant ascites
- Arterial thromboembolic events within 6 months prior to treatment
- Uncontrolled hypertension or prior hypertensive crisis
- Significant vascular disease within 6 months
- Bleeding disorders without therapeutic anticoagulation
- Recent gastrointestinal fistula, perforation, or obstruction
- Serious wounds, ulcers, or fractures within 28 days prior to treatment
- Smoking history over 100 cigarettes lifetime unless tumor has EGFR exon 19 or 21 mutation
- Active autoimmune disease requiring recent systemic treatment
- Recent hemoptysis or major blood vessel invasion by cancer
- Major surgery within 28 days or minor surgery within 7 days prior to treatment
- Chronic use of anti-platelet therapy other than aspirin
- Unresolved adverse events from prior therapies except neuropathy and alopecia
- Taking more than 10 mg prednisolone equivalent daily
- Interstitial lung disease or pneumonitis requiring steroids
- Known tuberculosis infection
- Live vaccine within 30 days prior to treatment
- Uncontrolled illness limiting study compliance
- Known HIV or AIDS
- Chronic hepatitis B or C infection not cured
- Previous malignancies unless remission for 2 years without treatment
- Leptomeningeal disease
- Uncontrolled tumor-related pain not stabilized
- High calcium levels unless managed with bisphosphonates
- Pregnant or breastfeeding
- Hypersensitivity to study drugs or Chinese hamster ovary cell products
- Prior bone marrow or solid organ transplant
- Tumor infiltration into thoracic great vessels or cavitation of lung lesions
- Diagnosis of squamous cell lung carcinoma
- Lung tumor with ALK or ROS1 rearrangement or EGFR mutations other than exon 19 or 21
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
J
Joseph Bodor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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