Clinical trial · Interventional
Sorafenib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Chemotherapy
A Multicenter, Open-label, Phase II Study of Sorafenib in Combination With Erlotinib in Non-small Cell Lung Cancer (NSCLC) Refractory to One or Two Prior Chemotherapy Regimens
- 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: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to chemotherapy.
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA analysis | Genetic | — | UNRESOLVED |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| protein analysis | Genetic | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor response based on RECIST criteria
Secondary outcomes (5)
- measure
- Response duration in patients with confirmed objective response
- measure
- Disease control rate
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Biomarker analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Advanced (stage IIIB-IV) or recurrent disease * Must have failed 1 or 2 prior chemotherapy regimens, including platinum-containing regimen * At least 1 unidimensionally measurable lesion \> 10 mm by spiral CT scan or \> 20 mm by conventional CT scan * Previously irradiated lesions cannot be included as sites of measurable disease unless clear tumor progression has been documented in the lesions since the end of radiotherapy * No known or suspected brain metastases * Patients with clinical signs or symptoms that are suspicious of brain metastasis must have a pre-treatment CT scan or MRI of the brain * Patients with prior brain metastases are eligible provided they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * WBC 4,000-12,000/μL * Neutrophil ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Hemoglobin ≥ 9.0 g/dL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.0 times ULN * Alkaline phosphatase ≤ 2.0 times ULN * Serum creatinine ≤ 1.5 times ULN * Not pregnant or nursing * No active clinically serious infections * No prior or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1), or any cancer curatively treated \> 5 years before study * Able to swallow oral medications * No substance abuse or medical, psychological, or social conditions that may interfere with participation in the study or evaluation of the study results PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy * No prior anti-EGFR targeted therapy * At least 4 weeks since prior surgery * At least 4 weeks since prior and no concurrent radiotherapy * No prior radiotherapy to the whole pelvis or chest or to ≥ 25% of the bone marrow * No other concurrent anticancer agents (e.g., chemotherapy or immunotherapy agents) which might affect evaluation of study treatment
References
Publications (1)
- DERIVEDLim SM, Cho BC, Kim SW, Kang SY, Heo DS, Kim HT, Lee DH, Kim DW, Jung M, Choi JH, Shim HS, Choi JR, Kim JH. A multicenter phase II study of sorafenib in combination with erlotinib in patients with advanced non-small cell lung cancer (KCSG-0806). Lung Cancer. 2016 Mar;93:1-8. doi: 10.1016/j.lungcan.2015.12.005. Epub 2015 Dec 29. PMID 26898607