Clinical trial · Interventional
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
A Phase I-II, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients With Resectable Stage I-III Non-Small Cell Lung Cancer, Selected According to Biomarker Status
- 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 objective of this study is to explore the safety of alectinib in combination with chemotherapy in participants with resectable NSCLC. Cohort B1 is a phase II cohort that will assess the safety of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alectinib | Drug | Alectinib | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort B1
- description
- Participants will receive alectinib in combination with a platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 2 years.
- interventionNames
- Drug: Alectinib
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy
- timeFrame
- Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)
Secondary outcomes (1)
- measure
- Incidence, Type, and Severity of AEs With Onset up to 28 Days After the Last Dose of Study Treatment or Until Last on Site/Discontinuation Visit, Whichever Comes First
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Complete resection of the primary NSCLC with negative margins * Confirmed stage II to select stage IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Documented ALK fusion Exclusion Criteria: * NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation * Prior exposure to any systemic anti-cancer therapy * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
References
Publications (0)
Data not yet available