Clinical trial · Interventional
Osimertinib and Bevacizumab as Treatment for EGFR-mutant Lung Cancers
A Phase 1/2 Study of Combination Osimertinib and Bevacizumab as Treatment for Patients With EGFR-mutant Lung Cancers
NCT02803203CI-TRIAL-00069870completedPhase 1 / Phase 2Results 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 test the safety of combining the drugs osimertinib and bevacizumab at different dose levels. The investigators want to find out what effects, good and/or bad, taking osimertinib and bevacizumab has on the patient and lung cancer. This study will try to find the best dose of osimertinib and bevacizumab given together that does not cause significant side effects. Once the investigators determine that combining osimertinib and bevacizumab is safe, they want to see if the combination is effective in treating lung cancers with the EGFR mutation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR-mutant Lung Cancers | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- osimertinib and bevacizumab
- description
- Phase 1: 3+3 dose escalation design 2 dose levels Dose level -1: Osimertinib 40mg daily Maximum accrual = 12 Bevacizumab 15mg/kg q3 weeks Dose level 1: Osimertinib 80mg daily Bevacizumab 15mg/kg q3 Weeks Phase 2: Use MTD determined during phase 1
- interventionNames
- Drug: osimertinib
- Drug: Bevacizumab
Primary outcomes (3)
- measure
- Osimertinib Maximum Tolerated Dose (MTD) (Phase I)
- timeFrame
- 1 year
- description
- The MTD (maximum tolerated dose)/recommended phase 2 dose will be the highest dose level at which \<1 DLT is detected in the first cycle for 6 treated patients. If only 3 patients are treated at a dose level being considered for the MTD, an additional 3 patients will be enrolled.
- measure
- Bevacizumab Maximum Tolerated Dose (MTD) (Phase I)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Advanced biopsy-proven metastatic non-small cell lung cancer * Somatic activating mutation in EGFR * No prior treatment with an EGFR TKI * No prior treatment with a VEGF inhibitor * Measurable (RECIST 1.1) indicator lesion not previously irradiated * Karnofsky performance status (KPS) ≥ 70% * Age \>18 years old * Adequate organ function * AST, ALT ≤ 3 x ULN * Total bilirubin ≤ 1.5x ULN * Creatinine ≤ 1.5x ULN OR calculated creatinine clearance \> 60ml/min * Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 * Hemoglobin≥8.0 g/dL * Platelets ≥100,000/mm3 Exclusion Criteria: * Any contra-indications to bevacizumab which include but are not limited to recent 1. Any previous venous thromboembolism \> NCI CTCAE Grade 3 2. Severe uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥ 100mmHg) 3. Cardiovascular disease including stroke of myocardial infarction \<6 months prior to study enrollment, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrythmia uncontrolled by medication 4. Hemorrhagic brain metastases. Asymptomatic (not requiring escalating doses of steroids) brain metastases are acceptable. 5. History of severe proteinuria (urine dipstick ≥ 2+ or 24 hr urine \> 2gm/24hr) 6. Prior history of hypertensive crisis or hypertensive encephalopathy 7. History of a central nervous system disease (e.g. seizures) unrelated to cancer unless adequately treated with standard medical therapy 8. Significant vascular disease (e.g. aortic aneurysm requiring surgical repair)≥ 6 months prior to study enrollment 9. History of hemoptysis (≥1/2 teaspoon of bright red blood per episode) within the last 3 months 10. Evidence of a bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) 11. Current or recent (within 10 days of study drug start) use of aspirin (\>325mg daily), clopidogrel (\>75mg daily). 12. Recent initiation of full dose oral or parental anticoagulants that have not been in place for at least 2 weeks. 13. Tumor invading or abutting major blood vessels 14. Tumor histology classified by squamous cell histology. 15. Any history of abdominal fistula or GI perforation within 6 months of study enrollment * Pregnant or lactating women * Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol * Any radiotherapy within 1 week of starting treatment on protocol * Any major surgery within 4 weeks of starting treatment on protocol * Any evidence of clinically significant interstitial lung disease * Known hypersensitivity to any component of bevacizumab and osimertinib
References
Publications (1)
- DERIVEDYu HA, Schoenfeld AJ, Makhnin A, Kim R, Rizvi H, Tsui D, Falcon C, Houck-Loomis B, Meng F, Yang JL, Tobi Y, Heller G, Ahn L, Hayes SA, Young RJ, Arcila ME, Berger M, Chaft JE, Ladanyi M, Riely GJ, Kris MG. Effect of Osimertinib and Bevacizumab on Progression-Free Survival for Patients With Metastatic EGFR-Mutant Lung Cancers: A Phase 1/2 Single-Group Open-Label Trial. JAMA Oncol. 2020 Jul 1;6(7):1048-1054. doi: 10.1001/jamaoncol.2020.1260. PMID 32463456