E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non Small Cell Lung Cancer |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066490 |
E.1.2 | Term | Progression of non-small cell lung cancer |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate Progression Free Survival (PFS) in patients who have ‘‘acquired resistance’’ to first line gefitinib |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate overall survival (OS)
2. To evaluate Objective Response Rate (ORR) and Disease Control Rate (DCR)
3. To evaluate symptoms and Health related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
4. To evaluate the safety and tolerability in patients
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)-Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 years or older)
2)-Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally
3)-Patients with documented 'acquired resistance’ on first line gefitinib
4)-Patients suitable to start cisplatin based pemetrexed combination chemotherapy.
5)-Provision of informed consent prior to any study specific procedures. |
|
E.4 | Principal exclusion criteria |
1)-Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib).
2)-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
3)-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
4)-Any evidence of severe of uncontrolled systemic disease
5)-Treatment with an investigational drug within 4 weeks before randomization |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival (PFS) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
An expected average of 48 weeks after last subject enrolled into our study |
|
E.5.2 | Secondary end point(s) |
1) Overall survival (OS) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients
with Pemetrexed & Cisplatin alone.
2) Object Response Rate (ORR) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to
patients with Pemetrexed & Cisplatin alone.
3) Disease Control Rate (DCR) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to
patients with Pemetrexed & Cisplatin alone.
4) Symptoms and HRQOL as measured by the FACT-L Trial Outcome Index (TOI) in patients with
Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone.
5) Safety and tolerability: Adverse events, Serious adverse events, incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) An expected average of 48 weeks after last subject enrolled into our study
2) An expected average of 48 weeks after last subject enrolled into our study
3) An expected average of 48 weeks after last subject enrolled into our study
4) An expected average of 48 weeks after last subject enrolled into our study
5) From time of informed consent until 30 days after discontinuation of gefitinib/placebo treatment. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
China |
France |
Germany |
Hong Kong |
Hungary |
Italy |
Japan |
Korea, Republic of |
Russian Federation |
Spain |
Taiwan |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the study is defined as the last visit of the last patient, occurring when the last patient has discontinued study therapy |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |