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

Conditions: on-small Cell Lung Cancer
MedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-005533-39-ES

Lead Sponsor: Debiopharm SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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/?L;
11. Platelets ? 100 000/?L;
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. If female, neither pregnant nor lactating;
15. 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.
16. Provide written informed consent;
17. 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;
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/?L;
11. Platelets ? 100 000/?L;
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. If female, neither pregnant nor lactating;
15. 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.
16. Provide written informed consent;
17. 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;
3. Archived tumour sample available unless previous participant in Part B;
4. Advanced or metastatic disease (Stage IIIb or IV) ;
5. Previous participant of Part B of the study with PD under study treatment;
6. New patients in case of futility of the interim analysis of Part B or in case of an insufficient number of patients enrolling from Part B: PD after dual chemotherapy with cisplatin/pemetrexed or cisplatin/gemcitabine.
7. Candidate for treatment with docetaxel as determined by the Investigator;
8. Measurable disease by the RECIST criteria;
9. ECOG performance score 0 - 1;
10. Life expectancy ? 3 months;
11. Absolute neutrophil count ? 1 500/?L;
12. Platelets ? 100 000/?L;
13. Creatinine clearance ? 60 mL/minutes (Cockroft ? Gault formula);
14. AST and ALT ? 2.5 x ULN; in case of documented liver metastases, AST and ALT ? 3.5 x ULN;
1

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.