NCT02289690
Brief summary
The study seeks to assess the efficacy of an active drug in combination with carboplatin and etoposide in participants with extensive disease small cell lung cancer (ED SCLC). ED SCLC is defined herein as any SCLC except a disease confined to the hemithorax of origin, with or without the involvement of regional lymph nodes, including ipsilateral and contralateral mediastinal, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular nodes
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 99 Years.
Inclusion Criteria:
1. Subject with histologically or cytologically confirmed extensive-stage disease SCLC
which is newly diagnosed and chemotherapy naive
2. Phase 1 ONLY: histologically or cytologically confirmed advanced/metastatic solid
tumors for which carboplatin/etoposide treatment is considered appropriate.
3. Subject in Phase 2 only: must have measurable disease per RECIST 1.1.
4. Subjects with ED SCLC must consent to provide available archived formalin fixed
paraffin embedded (FFPE) tissue sample of SCLC lesion (primary or metastatic) for
central review and biomarker analysis.
5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
6. Subject must have adequate hematologic, renal and hepatic function.
Exclusion Criteria:
1. Phase 1 ONLY: Subject has had any prior anti-cancer therapy other than:
Hormonal, non-myelosuppressive, biologic, targeted, or immune therapy (must be
completed ≥ 4 weeks prior to Cycle 1 Day -2).
One line of cytotoxic chemotherapy (must be completed ≥ 4 weeks prior to Cycle 1 Day
-2).
Adjuvant/neoadjuvant radiotherapy (must be completed ≥ 12 months prior to Cycle 1 Day
-2, with field not involving > 10% of bone marrow reserve).
2. Phase 2 ONLY: Subject has had any prior chemotherapy, radiotherapy, investigational
anti-cancer agents or biologic therapy for the disease under study. Single non-target
lesion irradiation with intent of symptom palliation is allowed if ≥ 4 weeks prior
Cycle 1 Day -2.
3. Subject has current central nervous system (CNS) or leptomeningeal metastases or
history of CNS or leptomeningeal metastases.
4. Subject has a history of seizures within 12 months of Cycle 1 Day-2 or diagnosed
neurological condition placing subject at the increased risk of seizures.
5. Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies
within 14 days prior to Cycle 1 Day-2.
6. Subject has had major surgery within 6 weeks prior to Cycle 1 Day-2 (subjects must
have completely recovered from any previous surgery prior Cycle 1 Day-2).
7. Subject has clinically significant and uncontrolled major medical condition(s)
including but not limited to:
- Uncontrolled nausea/vomiting/diarrhea;
- Active uncontrolled infection;
- History of hepatitis B (HBV) with surface antigen (HBsAg) positivity within 3
months prior to the date of informed consent for this study (if no test has been
performed within 3 months, it must be done at screening);
- History of hepatitis C (HCV) with HCV ribonucleic acid (RNA) positivity within 3
months prior to the date of informed consent for this study (if no test has been
performed within 3 months it must be done at screening);
- Symptomatic congestive heart failure (Yew York Heart Association [NYHA] class ≥
II);
- Unstable angina pectoris or cardiac arrhythmia (except atrial fibrillation);
- Psychiatric illness/social situation that would limit compliance with study
requirements;
- Any other medical condition, which in the opinion of the Investigator, places the
subject at an unacceptably high risk for toxicities.
8. The subject has a history of another active cancer within the past 3 years except
cervical cancer in situ, in situ carcinoma of the bladder, squamous or basal cell
carcinoma of the skin or another in situ cancer that is considered cured by the
investigator (e.g., in situ prostate cancer, breast DCIS).
