Clinical trial · Interventional
Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer
A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II 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)
This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC). A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: Pemetrexed + Cisplatin
- interventionNames
- Drug: pemetrexed
- Drug: cisplatin
- type
- EXPERIMENTAL
- label
- B: Pemetrexed + Carboplatin
- interventionNames
- Drug: pemetrexed
- Drug: carboplatin
Primary outcomes (1)
- measure
- The Feasibility of Post-Surgery Chemotherapy
- timeFrame
- every 21-day cycle for 4 cycles up to 30 days after last infusion
- description
- Feasibility was measured by completion of 4 treatment cycles without remaining toxicities \>=Grade 3 at 30 days after last infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven non-small cell lung cancer stage Ib, IIa or IIb * Must have complete tumor resection by pneumonectomy or lobectomy * Must have been surgically proven to be N2 negative Exclusion Criteria: * Serious concomitant systemic disorder * Post-operative complications or other surgery related conditions * A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago
References
Publications (0)
Data not yet available