Phase 3
Completed N=265
A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone
Source: ClinicalTrials.gov NCT01544179 ↗Enrolled (actual)
265
Serious AEs
25.0%
Results posted
Feb 2016
Primary outcomePrimary: Progression-Free Survival (Site Read, Investigator Assessment) — 98; 107 Patients with a progression event — p=0.273
Summary
The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (Site Read, Investigator Assessment) |
98; 107 | 0.273 |
| PRIMARY Median Progression-Free Survival (Site Read, Investigator Assessment) |
5.4; 5.4 | — |
| SECONDARY Overall Survival (OS) |
50; 37 | — |
| SECONDARY Median Overall Survival (OS) at Time of PFS Analysis |
14.8; 17.2 | 0.029 sig |
| SECONDARY Objective Response Rate (ORR) (Site Read Data) |
31.6; 34.1 | 0.760 |
| SECONDARY Disease Control Rate (DCR) |
84.2; 78.8 | 0.308 |
| SECONDARY Improvement in Trial Outcome Index |
36; 39 | 0.770 |
| SECONDARY Time to Worsening in Trial Outcome Index |
12.1; 9.4 | 0.507 |
| SECONDARY Improvement in FACT-L Total Score |
44; 49 | 0.725 |
| SECONDARY Time to Worsening in FACT-L Total Score |
12.0; 8.9 | 0.575 |
| SECONDARY Improvement in Lung Cancer Subscale |
54; 55 | 0.959 |
| SECONDARY Time to Worsening in Lung Cancer Subscale |
14.6; 9.1 | 0.437 |
Eligibility Criteria
Inclusion Criteria
- Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 years or older)
- Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally
- Patients with documented 'acquired resistance' on first line gefitinib
- Patients suitable to start cisplatin based pemetrexed combination chemotherapy.
- Provision of informed consent prior to any study specific procedures.
Exclusion Criteria
- Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). Palliative bone radiotherapy must be completed at least 2 weeks before start of study treatment with no persistent radiation toxicity).
- Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer
- Any evidence of severe of uncontrolled systemic disease Treatment with an investigational drug within 4 weeks before randomization
Data sourced from ClinicalTrials.gov (NCT01544179). 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.