Table 1.
Key Inclusion and Exclusion Criteria for the KEYLYNK-013 Study
| Inclusion Criteria | Exclusion Criteria |
|---|---|
|
| |
| • Age ≥18 years | • Extensive-stage SCLC, defined as stage IV or T3–4 that cannot be encompassed in a tolerable radiation plan |
| • Histologically/cytologically confirmed, newly diagnosed, limited-stage (stage I-III by AJCC eighth edition) SCLC that can be safely treated with radiotherapy | • Known MDS/AML, or features suggestive of MDS/AML |
| • At least 1 measurable lesion per RECIST version 1.1 as assessed by the local investigator | • Documented >10% weight loss from baseline in the preceding 3 months |
| • No evidence of metastatic disease | • Prior olaparib or other PARP inhibitor therapy or prior anti-PD-1, PD-L1, PD-L2 or other stimulatory or co-inhibitory T-cell receptor therapy |
| • No prior chemotherapy, radiotherapy or surgery for limited-stage SCLC | • Major surgery <4 weeks prior to initiation of study treatment |
| • Not expected to require tumor resection during the course of the study | • Received colony-stimulating factors ≤28 days prior to initiation of study treatment |
| • Provision of newly obtained (strongly preferred) or archival tumor tissue sample for PD-L1 assessment | • Known additional malignancy that is progressing or required active treatment ≤5 years prior to initiation of study treatment |
| • ECOG PS of 0 or 1 | • Uncontrolled, potentially reversible cardiac conditions |
| • Adequate pulmonary function testing, defined as a FEV1 >50% of predicted normal volume and a DLCO >40% of predicted normal value | • History of/current pneumonitis or interstitial lung disease |
| • Adequate organ function | • Active infection requiring systemic therapy |
| • Life expectancy at least 6 months | • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy ≤7 days prior to initiation of study treatment |
| • Written informed consent | • Active autoimmune disease requiring systemic treatment in the past 2 years |
| • Known history of HIV or Hepatitis B or active Hepatitis C infection | |
Abbreviations: AJCC = American Joint Committee on Cancer; AML = acute myeloid leukemia; DLCO = carbon monoxide lung diffusing capacity; ECOG PS = Eastern Cooperative Oncology Group performance status; FEV = forced expiratory volume; HIV = human immunodeficiency virus; MDS = myelodysplastic syndrome; PARP = poly (ADP-ribose) polymerase; SCLC = small-cell lung cancer.