Clinical trial · Interventional
Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer
Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study
- 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)
This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations. Expanded acronym : \[P\]aclitaxel/Ca\[r\]boplatin (PC) followed by Gef\[i\]tinib in A\[d\]vanc\[e\]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel/Carboplatin | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| Paclitaxel/Carboplatin/Gefitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paclitaxel/Carboplatin/Gefitinib
- description
- Paclitaxel/Carboplatin/Gefitinib
- interventionNames
- Drug: Paclitaxel/Carboplatin/Gefitinib
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel/Carboplatin
- description
- Paclitaxel/Carboplatin
- interventionNames
- Drug: Paclitaxel/Carboplatin
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- average 6 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * More than 18 years of age * Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion. * At least 1 measurable lesion as defined by RECIST1.0. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment. * ECOG PS 0-2 * At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy. * Patients must have adequate hematologic, renal and liver function as defined by Hb \> 9g/dL, neutrophils \> 1000/mm3, platelets \> 50,000/mm3, creatinine \< 2mg/dL, and AST (SGOT) and/or ALT (SGPT) \< 5 x UNL (upper normal limit). * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. * Written and voluntary informed consent understood, signed and dated. Exclusion Criteria: * Patients with tumor harboring EGFR mutation. * Prior systemic therapy for NSCLC * Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study. * Symptomatic brain metastasis. Brain metastases stable \< 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms. * Major surgery within 3 weeks prior to study enrollment. * Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin. * Severe medical illness or active infection that would impair the ability to receive gefitinib. * Pregnancy or breast feeding.
References
Publications (1)
- DERIVEDChoi YJ, Lee DH, Choi CM, Lee JS, Lee SJ, Ahn JH, Kim SW. Randomized phase II study of paclitaxel/carboplatin intercalated with gefitinib compared to paclitaxel/carboplatin alone for chemotherapy-naive non-small cell lung cancer in a clinically selected population excluding patients with non-smoking adenocarcinoma or mutated EGFR. BMC Cancer. 2015 Oct 22;15:763. doi: 10.1186/s12885-015-1714-y. PMID 26493267