Clinical trial · Interventional
Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
- 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 gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV 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 |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Length of survival
Secondary outcomes (6)
- measure
- Symptom control and quality of life as measured by the EORTC Quality of Life Questionnaire Core 30 Items and Lung Cancer supplement 13 together with EuroQol-5 domain questionnaire
- measure
- Treatment response as measured by RECIST criteria
- measure
- Dose intensity of chemotherapy
- measure
- Ratio of treatment courses given as in-patient versus out-patient
- measure
- Toxicity as measured by CTCAE v3.0
- measure
- Treatment cost
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 (NSCLC), meeting 1 of the following stage criteria: * Stage IIIB disease\* that is not suitable for radical radiotherapy * Stage IV disease\* NOTE: \*Radiographically verified * At least 1 measurable lesion by clinical examination or radiography * No mixed histologies of small cell lung cancer and NSCLC * No clinically apparent brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * At least 12 weeks Hematopoietic * WBC ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL Hepatic * AST \< 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Alkaline phosphatase \< 3 times ULN * Bilirubin \< 1.5 times ULN Renal * Creatinine clearance ≥ 60 mL/min (by Wright equation) OR ≥ 70 mL/min (by \^51Cr-EDTA clearance) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able and willing to participate in the quality of life assessment * No pre-existing neuropathy \> grade 2 * No other malignancy that would preclude study treatment or study comparisons * No evidence of severe or uncontrolled systemic disease, significant clinical disorder, or laboratory finding that would preclude study participation * No psychiatric disorder that would preclude study participation * No other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy * No other concurrent cytotoxic chemotherapy Endocrine therapy * No concurrent hormonal therapy except contraceptives or replacement steroids Radiotherapy * No prior radiotherapy Surgery * Recovered from prior surgery * Prior surgical resection for NSCLC allowed Other * More than 12 weeks since prior investigational agents and recovered * No other concurrent specific antitumor therapy * No other concurrent investigational agents
References
Publications (2)
- DERIVEDGijtenbeek RG, de Jong K, Venmans BJ, van Vollenhoven FH, Ten Brinke A, Van der Wekken AJ, van Geffen WH. Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status. Cochrane Database Syst Rev. 2023 Jul 7;7(7):CD013382. doi: 10.1002/14651858.CD013382.pub2. PMID 37419867
- DERIVEDFerry D, Billingham L, Jarrett H, Dunlop D, Woll PJ, Nicolson M, Shah R, Thompson J, Spicer J, Muthukumar D, Skailes G, Leonard P, Chetiyawardana AD, Wells P, Lewanski C, Crosse B, Hill M, Gaunt P, O'Byrne K. Carboplatin versus two doses of cisplatin in combination with gemcitabine in the treatment of advanced non-small-cell lung cancer: Results from a British Thoracic Oncology Group randomised phase III trial. Eur J Cancer. 2017 Sep;83:302-312. doi: 10.1016/j.ejca.2017.05.037. Epub 2017 Aug 4. PMID 28780466