Clinical trial · Interventional
Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
A Phase IIa, Open-Label, Multi-Center, Multi-Cohort, Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
NCT02179671CI-TRIAL-00039864completedPhase 2Results postedClinicalTrials.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)
Primary objective: To assess the efficacy of various sequences of either a small molecule or an IMT (IMT-A) followed by a IMT-B (MEDI4736) .
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 |
|---|---|---|---|
| Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV) | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD9291 | Drug | Osimertinib | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
| Selumetinib+Docetaxel | Drug | — | UNRESOLVED |
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Gefitinib with a Seq. Switch to a MEDI4736
- description
- Gefitinib once daily followed by MEDI4736
- interventionNames
- Drug: Gefitinib
- type
- EXPERIMENTAL
- label
- AZD9291 with a Seq. Switch to a MEDI4736
- description
- AZD9291 once daily followed by MEDI4736
- interventionNames
- Drug: AZD9291
- type
- EXPERIMENTAL
- label
- Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736
- description
- Selumetinib twice daily + docetaxel, followed by MEDI4736
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of archived tumor tissue sample and mandatory tissue biopsy * Patients must have either histologically or cytologically documented NSCLC who present with locally advanced or metastatic stage IIIB-IV disease * Life expectancy ≥12 weeks * Patients must have measurable disease and at least 1 lesion not previously irradiated * World Health Organization (WHO) performance status of 0 or 1 Exclusion Criteria: * Mixed small cell and NSCLC histology * Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
References
Publications (0)
Data not yet available
No reference posted for this study.