A trial to evaluate how well trilaciclib works in people with limited-stage small cell lung cancer

Prior treatment

• Receipt of a live, attenuated vaccine within 30 days prior to the first dose of IMP or anticipation that such a live, attenuated vaccine will be required during the trial treatment period. Inactive vaccines, including but not limited to influenza vaccine, pneumococcal vaccine, shingles vaccine, and regionally approved Covid-19 vaccines are allowed
• Prior allogeneic or autologous haematopoietic stem cell or bone marrow transplantation
• Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or prostate-specific antigen persistence/recurrence without metastatic disease) within 3 weeks prior the first dose of trilaciclib/placebo
• Clinically significant (i.e., active) cardiovascular disease at the time of signing the ICF, e.g., cerebrovascular accidents (≤6 months before the first dose of trilaciclib/placebo), myocardial infarction (≤6 months before the first dose of trilaciclib/placebo), unstable angina, serious cardiac arrythmia requiring medication, or uncontrolled symptomatic congestive heart failure (class II or higher as defined by the NYHA)

Other illness

• History of cisplatin, carboplatin, etoposide, or trilaciclib treatment for SCLC
• History of grade ≥2 interstitial lung disease/pneumonitis (except for resolved infective pneumonia)
• Known serious active infection including but not limited to, HIV (e.g., viral load indicative of HIV and HIV 1/2 antibodies), hepatitis B (e.g., hepatitis B surface antigen reactive or hepatitis B DNA detected), hepatitis C (e.g., hepatitis C RNA detected) or tuberculosis
• Known hypersensitivity or allergy to trilaciclib, cisplatin, carboplatin, or etoposide or any component in their formulations

Lab values

• Any laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the participant’s disease management at risk or may result in the participant being unable to comply with the trial requirements

Age

• History of other malignancies, except for curatively treated solid tumours with no evidence of disease for ≥2 years or other non-clinically significant cancers (e.g., basal or squamous cell carcinoma of the skin and in situ carcinoma of the uterine cervix) which may be considered after discussion with the Medical Monitor

Other

• ES-SCLC
• Pregnant or nursing women
• QTcF interval >480 msec at screening (confirmed on repeat). For participants with ventricular pacemakers, QTcF >500 msec

• Women and men aged ≥18 years
• Confirmed diagnosis of SCLC by histology or cytology with clinical and pathologic staging that confirms limited stage (according to VALSG or AJCC/UICC 8th edition – Stage I-III) with the absence of distant metastases
• ECOG performance status of 0 or 1
• Eligible to receive concurrent CRT
• Measurable or evaluable disease as defined by RECIST guideline version 1.1
• Adequate organ functioning as demonstrated by the following laboratory values: • Hb ≥9 g/dL in the absence of RBC transfusion or ESA administration within 14 days prior to first dose of IMP • ANC ≥1.5 × 109/L • Platelet count ≥100 × 109/L • eGFR ≥ 60 mL/minute/1.73 m2 • Total bilirubin ≤1.5 × ULN (<3 × ULN if Gilbert’s disease) • ALT and AST ≤2.5 × ULN • Albumin ≥3 g/dL
• Complete recovery from prior anti-tumour surgical procedures
• Acceptance of using contraceptives as described in Section 16 or where local regulations impose stricter requirements for contraception, those stricter requirements apply
• Willingness to participate and signing the ICF