E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor or who have responded to EGFR TKI |
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E.1.1.1 | Medical condition in easily understood language |
Non-small cell lung cancer |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025054 |
E.1.2 | Term | Lung cancer non-small cell stage IIIB |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025055 |
E.1.2 | Term | Lung cancer non-small cell stage IV |
E.1.2 | System Organ Class | 100000004864 |
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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 study efficacy and safety of Erlotinib treatment beyound diasease progression in combination with chemotherapy compared to chemotherapy alone in stage IIIB/IV non-small cell lung cancer patients with EGFR activating mutations or who have responded EGFR TKIs- |
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E.2.2 | Secondary objectives of the trial |
Overall survival, Objective response rate, Rate of non-progression at 9 and 18wks, Safety of the treatment, Predictive biomarkers for response and resistance |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed informed consent obtained prior to any study specific screening procedures.
2. Histologically confirmed stage IIIB/IV NSCLC.
3. Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
4. Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting > 6 months
5. Age >18
6. Performance status: WHO 0-2
7. Measurable disease according to RECIST 1.1
8. Patients must be able to comply with study treatments
9. Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
10. Neutrophils < 1’000/ul, Platelets < 100’000/ul, Alanine amino transferase < 2.5 x Upper limt of normal (ULN) (< 5 x ULN if liver metastases), Alkaline phosphatase < 2.5 x ULN (< 5 x ULN if liver metastases), Serum bilirubin < 1.5 x ULN, Serum Creatinine < 1.5 x ULN.
11. Patient must be able to comply with the protocol
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E.4 | Principal exclusion criteria |
1. Previous EGFR TKI treatment beyond RECIST 1.1 defined disease progression for more than 28 days
2. Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment
3. Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib
4. Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study
5. Patient with symptomatic central nervous system metastases
6. Patient has known active hepatitis B or C, or HIV infection
7. Pregnant or breastfeeding.
8. Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free survival |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Every nine weeks or three chemotherapy cycles (three week cycles) |
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E.5.2 | Secondary end point(s) |
Overall survival, Objective response rate, Rate of non-progression at 9 and 18wks, Safety |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Objective response rate: Every nine weeks or three chemotherapy cycles
Rate of non-progression at 9 and 18wks: at 9 and 18wks of treatment
Overall Survival, Safety: Continuosly |
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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 | No |
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 | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |