Clinical trial · Interventional
Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79
- 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)
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.
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 |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Investigational Treatment
- description
- Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
- interventionNames
- Drug: Pemetrexed
- Drug: Cetuximab
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab
- timeFrame
- 12 months
- description
- The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab
- measure
- Time To Progression (TTP)
- timeFrame
- 24 Months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of NSCLC * Recurrent or metastatic disease that is not amenable to curative therapyMeasurable disease according to RECIST * At least one prior platinum containing regimen for either locally advanced or metastatic disease * Prior chemotherapy must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen * Ability and willingness to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period * Prior radiation therapy allowed to \< 25% of the bone marrow * Negative pregnancy test Exclusion Criteria: * No active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy. * No serious concomitant systemic disorders that would compromise the safety of the subject or compromise the subject's ability to complete the study, at the discretion of the investigator. * No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least 2 years. * No major thoracic or abdominal surgery within 30 days prior to being registered for protocol therapy. * No current breastfeeding
References
Publications (1)
- RESULTJalal S, Waterhouse D, Edelman MJ, Nattam S, Ansari R, Koneru K, Clark R, Richards A, Wu J, Yu M, Bottema B, White A, Hanna N. Pemetrexed plus cetuximab in patients with recurrent non-small cell lung cancer (NSCLC): a phase I/II study from the Hoosier Oncology Group. J Thorac Oncol. 2009 Nov;4(11):1420-4. doi: 10.1097/JTO.0b013e3181b624ae. PMID 19701110