Clinical trial · Interventional
CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer
Randomized Phase II Study of Cetuximab in Combination With Gemcitabine or Gemcitabine Followed by Cetuximab in Advanced Non Small-cell Lung Cancer Patients Who Are Not Candidates for Platinum Based Therapy.
NCT00330746CI-TRIAL-00006946CALC-1completedPhase 2ClinicalTrials.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 select the more promising method of combining cetuximab with gemcitabine for treating patients with advanced non small-cell lung cancer, who are not candidates for platinum based therapy.
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 |
|---|---|---|---|
| Advanced Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- cetuximab and gemcitabine combination
- interventionNames
- Drug: cetuximab
- Drug: gemcitabine
- type
- EXPERIMENTAL
- label
- B
- description
- gemcitabine followed by cetuximab (sequential)
- interventionNames
- Drug: gemcitabine
- Drug: cetuximab
Primary outcomes (1)
- measure
- one year survival rate
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * Age \> 18 * Histological diagnosis of non small-cell lung cancer (NSCLC) * Stage III B or Stage IV disease * Contraindications to platinum based therapy (age \> 70 or age \< 70 with ECOG performance status 2) * At least one site of metastasis (target or non-target) * Life expectancy of at least 3 months * ECOG \<3 * Neutrophils \> 1500/mm3, platelets \> 100,000/mm3, hemoglobin \> 9g/dl * Bilirubin \< 1.5 x the upper normal limit * SGOT and SGPT \< 2.5 x the upper normal limits (\< 5 x the upper normal limit in the presence of hepatic metastasis) * Creatinine \< 1.5 x the upper normal limit * Adequate method of contraception (male and female), when there is risk of conception. Exclusion Criteria: * Symptomatic cerebral metastasis * Previous chemotherapy for advanced disease * Adjuvant chemotherapy within the previous 6 months * Radiation therapy within previous 4 weeks * Any experimental drug therapy within the previous 4 weeks * Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy * Clinically relevant cardiopathy or myocardial infarct within the last 12 months * Acute or subacute intestinal occlusion or history of inflammatory bowel disease * Known allergy to one or more of the experimental treatments * Known alcohol or substance abuse * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent * Pregnant or breastfeeding females * History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
References
Publications (2)
- RESULTGridelli D, Mencoboni M, Carrozza F, Viganò MG, Gebbia V, Verusio C, Maione P, Gallo C, Perrone F, Ciardiello F. Cetuximab (C) and gemcitabine (G) in elderly or adult PS2 advanced non small-cell lung cancer (NSCLC) patients (pts): The CALC1 randomised phase II trials. Journal of Clinical Oncology 26: 2008 (May 20 suppl; abstr 8117)
- RESULTGridelli C, Morabito A, Gebbia V, Mencoboni M, Carrozza F, Vigano MG, Verusio C, Bollina R, Mattioli R, Valerio MR, Valmadre G, Maione P, Rossi A, Cascone T, Morgillo F, Di Maio M, Piccirillo MC, Gallo C, Perrone F, Ciardiello F. Cetuximab and gemcitabine in elderly or adult PS2 patients with advanced non-small-cell lung cancer: The cetuximab in advanced lung cancer (CALC1-E and CALC1-PS2) randomized phase II trials. Lung Cancer. 2010 Jan;67(1):86-92. doi: 10.1016/j.lungcan.2009.03.021. PMID 19380175