Clinical trial · Interventional
Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
- 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 and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving gemcitabine and carboplatin together with AZD2171 may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and carboplatin together with AZD2171 works compared to giving gemcitabine and carboplatin without AZD2171 as first-line therapy in treating patients with stage IIIB 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 |
| cediranib maleate | Drug | Cediranib | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral AZD2171 once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. Patients achieving stable disease, partial response, or complete response after 6 courses of therapy receive AZD2171 alone as above. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: carboplatin
- Drug: cediranib maleate
- Drug: gemcitabine hydrochloride
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive gemcitabine and carboplatin as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: carboplatin
- Drug: gemcitabine hydrochloride
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) * Squamous cell histology allowed * No mixed histology with small cell component * Stage IIIB (with pleural effusion) or stage IV disease * Presence of peritoneal or pericardial effusion alone in the absence of cytologic evidence is not allowed * Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan * If the only site of measurable disease was previously irradiated, progressive disease must be evident * Ineligible for bevacizumab therapy * No symptomatic, untreated, or uncontrolled CNS metastases * CNS metastases treated with whole-brain radiation (WBRT) allowed 4 weeks after completion of WBRT PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 3 times upper limit of normal (ULN) * ALT and AST ≤ 3 times ULN (5 times ULN if liver involvement) * Alkaline phosphatase ≤ 5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception * No proteinuria ≥ 1+ * No uncontrolled blood pressure (BP), defined as systolic BP \> 150 mm Hg and/or diastolic BP \> 100 mm Hg in spite of adequate antihypertensive therapy * No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD2171 (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or small bowel resection) * No seizure disorder * No significant traumatic injury within 4 weeks prior to study entry * No second primary malignancy except any of the following: * Carcinoma in situ of the cervix * Nonmelanoma skin cancer * Prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence * History of low-grade (Gleason score ≤ 6) localized prostate cancer even if diagnosed \< 5 years prior to registration * Treated stage I breast cancer ≤ 5 years prior to registration * No uncontrolled intercurrent illness, including, but not limited to, any of the following: * Ongoing or active infection * Significant pulmonary symptoms at baseline due to disease * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would limit compliance with study requirements * Baseline hemoptysis * Cavitating lesions * No QTc prolongation \> 500 msec or other significant ECG abnormality within the past 14 days * No New York Heart Association class III or IV disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy for advanced lung cancer * Neoadjuvant or adjuvant therapy for lung cancer within the past 12 months allowed * More than 12 months since prior immunotherapy and biologic therapy * More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases) * At least 2 weeks since prior WBRT * No radiotherapy to ≥ 25% of bone marrow * No major surgery (i.e., laparotomy) or open biopsy within 4 weeks prior to study entry (2 weeks for minor surgery) * Insertion of a vascular access device not considered major or minor surgery * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent grapefruit or grapefruit juice during AZD2171 treatment * No concurrent drugs or biologics with proarrhythmic potential * Concurrent palliative radiotherapy to nontarget sites (i.e., painful pre-existing bony metastasis) allowed with AZD2171 (chemotherapy is held until completion of radiotherapy)
References
Publications (2)
- BACKGROUNDvan Cruijsen H, Voest EE, van Herpen CM, et al.: Phase I evaluation of AZD2171, a highly potent, selective VEGFR signaling inhibitor, in combination with gefitinib, in patients with advanced tumors. [Abstract] J Clin Oncol 24 (Suppl 18): A-3017, 125s, 2006.
- RESULTDy GK, Mandrekar SJ, Nelson GD, Meyers JP, Adjei AA, Ross HJ, Ansari RH, Lyss AP, Stella PJ, Schild SE, Molina JR, Adjei AA. A randomized phase II study of gemcitabine and carboplatin with or without cediranib as first-line therapy in advanced non-small-cell lung cancer: North Central Cancer Treatment Group Study N0528. J Thorac Oncol. 2013 Jan;8(1):79-88. doi: 10.1097/JTO.0b013e318274a85d. PMID 23232491