A clinical trial to study the safety and effectiveness of Debio 0932 in combination with standard of care in non-small cell lung cancer

Phase 1

Conditions: on-small Cell Lung Cancer
MedDRA version: 16.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864
MedDRA version: 16.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-005533-39-GB

Lead Sponsor: Debiopharm International SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 298

Inclusion Criteria

Part A :
1. Age = 18 years;
2. Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known EGFR mutation;
3. Archived tumour sample available;
4. Advanced or metastatic disease (Stage IIIb or IV) ;
5. Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if > 6 months ago); Patients to be treated with docetaxel: = 1 previous treatment with chemotherapy.
6. Candidate for treatment with cisplatin/pemetrexed or cisplatin/gemcitabine or docetaxel as determined by the Investigator;
7. Measurable disease by the RECIST criteria;
8. ECOG performance score 0 - 1;
9. Life expectancy = 3 months;
10. ANC = 1 500/µL;
11. Platelets = 100 000/µL;
12. Creatinine clearance = 60 mL/minutes (Cockroft – Gault formula);
13. AST and ALT = 2.5 x ULN; in case of documented liver metastases, AST and ALT = 3.5 x ULN;
14. LVEF = 55% on cardiac ultrasound;
15. If female, neither pregnant nor lactating;
16. Women of child-bearing potential:
a. Negative pregnancy test at screening;
b. Agreement to use appropriate contraception methods from study entry to 6 months after the last day of treatment;
17. Male patients agree to use contraception methods from study entry to 6 months after the last day of treatment;
18. Provide written informed consent;
19. Ability to comply with study procedures.

Part B :
1. Age = 18 years;
2. Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known EGFR mutation and with known KRAS status;
3. Archived tumour sample available;
4. Advanced or metastatic disease (Stage IIIb or IV) ;
5. No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if > 6 months ago) ;
6. Candidate for treatment with cisplatin/pemetrexed or cisplatin/gemcitabine as determined by the Investigator;
7. Measurable disease by the RECIST criteria;
8. ECOG performance score 0 - 1;
9. Life expectancy = 3 months;
10. Absolute neutrophil count = 1 500/µL;
11. Platelets = 100 000/µL;
12. Creatinine clearance = 60 mL/minutes (Cockroft – Gault formula);
13. AST and ALT = 2.5 x ULN; in case of documented liver metastases, AST and ALT = 3.5 x ULN;
14. LVEF = 55% on cardiac ultrasound;
15. If female, neither pregnant nor lactating;
16. Women of child-bearing potential:
a. Negative pregnancy test at screening;
b. Agreement to use appropriate contraception methods from study entry to 6 months after the last day of treatment.
17. Male patients agree to use contraception methods from study entry to 6 months after the last day of treatment;
18. Provide written informed consent;
19. Ability to comply with study procedures.

Part C :
1. Age = 18 years;
2. Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known EGFR mutation and with known KRAS status;
3. Archived tumour sample available unless previous participant in Part B;
4. Advanced or metastatic disease (Stage IIIb or IV) ;
5. One of these two criteria should be fulfilled:
a) Previous participant of Part B with PD under study treatment or
b) New patient in case of futility of the interim analysis of Part B or in case of an insufficient number of patients enrolling from Part B with PD after dual chemotherapy with cisplatin/pemetrexed or cisplatin/gemcitabine or for any other re

Exclusion Criteria

Part A :
1. Unresolved toxicity from previous treatment;
2. Symptomatic brain metastases;
3. For patients on docetaxel: Serum bilirubin levels > ULN associated with serum ALP levels > 6 times ULN;
4. Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease);
5. Concurrent treatment with any other systemic anti-cancer therapy;
6. Concomitant treatment with any drug on the prohibited medication list (provided separately);
7. Serious concomitant uncontrolled medical conditions.

Part B :
1. Unresolved toxicity from previous treatment;
2. Symptomatic brain metastases;
3. Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease);
4. Concurrent treatment with any other systemic anti-cancer therapy;
5. Concomitant treatment with any drug on the prohibited medication list (provided separately);
6. Serious concomitant uncontrolled medical conditions.

Part C :
1. Unresolved toxicity from previous treatment;
2. Symptomatic brain metastases;
3. Serum bilirubin levels > ULN associated with serum ALP levels > 6 times ULN;
4. Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease) ;
5. Concurrent treatment with any other systemic anti-cancer therapy;
6. Concomitant treatment with any drug on the prohibited medication list (provided separately);
7. Serious concomitant uncontrolled medical conditions.