Phase 2
Completed N=32
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
Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
Source: ClinicalTrials.gov NCT02179671 ↗
Enrolled (actual)
32
Serious AEs
46.7%
Results posted
Aug 2019
Primary outcomePrimary: Confirmed Complete Response (CR) Rate — 0; 0 patients (%)
Summary
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) .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Complete Response (CR) Rate |
0; 0 | — |
| SECONDARY Objective Response Rate (ORR) |
11.1; 0 | — |
| SECONDARY Progression-free Survival |
1; 0 | — |
| SECONDARY Duration of Response |
NA | — |
| SECONDARY Overall Survival |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02179671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.