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ALIMTA (pemetrexed disodium) as second-line treatment of non-small-cell lung cancer: a phase II study
E F Smit1, K Mattson, J von Pawel
1Department of Pulmonary Diseases, Vrije Universiteit Medical Center Amsterdam, The Netherlands.
Background:
The purpose of this study was to evaluate ALIMTA (pemetrexed disodium, LY231514), a multi-targeted antifolate with first-line activity against non-small-cell lung cancer (NSCLC), in a second-line setting.
Patients And Methods:
Patients with NSCLC were eligible for this phase II study if they had progressive disease within 3 months after first-line chemotherapy or progression while being treated with first-line chemotherapy. In 81 patients studied, two cohorts of patients were assigned based on whether the first-line therapy had included a platinum regimen. ALIMTA was administered at 500 mg/m2 by 10-min intravenous infusion once every 21 days.
Results:
The response rate in the 79 evaluable patients with poor prognostic features was 8.9% [95% confidence interval (CI) 2.6% to 15.1%]. The response rate in the platinum-pretreated group was 4.5% and 14.1% in the non-platinum-pretreated group. The median duration of response was 6.8 months (95% CI 3.4-7.8 months, 0% censoring). The median survival time was 5.7 months (95% CI 4.0-8.3 months, 7.6% censoring). The probability of survival for at least 6 months was estimated to be 48%. The median time to disease progression was 2 months (95% CI 1.4-2.8 months, 0% censoring). The principal toxicity was myelosuppression, which was reversible.
Conclusions:
ALIMTA is active in a second-line setting in non-platinum-pretreated NSCLC patients progressing within 3 months of first-line chemotherapy. This study demonstrates that it is possible to evaluate new drugs against NSCLC in a second-line setting.
Insights
Pemetrexed (ALIMTA) shows activity as a second-line treatment for non-small-cell lung cancer (NSCLC) patients who did not receive platinum-based chemotherapy. This study confirms the feasibility of evaluating new NSCLC drugs in the second-line setting.
Area of Science:
- Oncology
- Medical Oncology
- Clinical Pharmacology
Background:
- Non-small-cell lung cancer (NSCLC) remains a leading cause of cancer mortality.
- Effective second-line therapies are crucial for patients with progressive NSCLC after initial treatment.
- Multi-targeted antifolates represent a promising class of chemotherapeutic agents.
Purpose of the Study:
- To evaluate the efficacy and safety of pemetrexed disodium (ALIMTA) as a second-line treatment for NSCLC.
- To assess ALIMTA's activity in patients with disease progression after first-line chemotherapy.
- To explore the role of prior platinum-based therapy on treatment outcomes.
Main Methods:
- A Phase II clinical trial was conducted in 81 patients with NSCLC.
- Patients had progressive disease within 3 months of first-line chemotherapy.
- ALIMTA was administered intravenously at 500 mg/m2 every 21 days, with patient cohorts stratified by prior platinum-based chemotherapy.
Main Results:
- An overall response rate of 8.9% was observed in evaluable patients.
- Response rates were 4.5% in platinum-pretreated and 14.1% in non-platinum-pretreated groups.
- The primary toxicity was reversible myelosuppression; median survival was 5.7 months.
Conclusions:
- Pemetrexed (ALIMTA) demonstrates activity in the second-line treatment of NSCLC, particularly in patients not previously treated with platinum agents.
- The study supports the evaluation of novel agents in the second-line setting for NSCLC.
- ALIMTA is a viable option for NSCLC patients progressing after initial chemotherapy.
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