Patients With ES-SCLC and ECOG PS=2 Receiving Atezolizumab-Carboplatin-Etoposide
Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
Small cell lung cancer (SCLC) is a rapidly proliferating, neuroendocrine tumor that accounts
for about 15% of all lung cancers. Most patients have metastases at primary diagnosis
involving sites like bone, adrenal glands, liver and brain.
Compared with non-small-cell lung cancer (NSCLC) SCLC has a unique natural history with a
shorter doubling time, higher growth fraction, earlier development of widespread metastases,
and uniform initial response to chemo- or radiotherapy.
The combination of cis- or carboplatin and etoposide is the standard of care in the
first-line treatment of stage IV (extensive-disease) SCLC (ED-SCLC). Despite response rates
of 50-80%, most patients relapse within six months and the median survival time is less than
10 months. Between 14 and 23% of SCLC patients develop brain metastases.
New cytotoxic agents as well as targeted therapies have not been able to show any improvement
of survival in this group of patients.
Early phase trials of PD 1/PD L1-blocking immunotherapeutic agents in patients with recurrent
or ED SCLC have shown promising response rates and good tolerability. Immunotherapy may also
contribute to the efficacy of systemic treatment by maintaining initial responses to
chemotherapy. A double-blind, placebo-controlled phase 3 trial indicates that the addition of
atezolizumab to standard chemotherapy significantly improves overall survival and
progression-free survival compared with chemotherapy alone in treatment-naïve patients with
ED-SCLC who are in good general condition (ECOG 0 or 1). However, about one in three SCLC
patients has a poor performance status (ECOG≥2), which is associated with even shorter
survival times of under eight months. At present, there is little information regarding the
feasibility, safety and efficacy of adding atezolizumab to standard chemotherapy for this
considerable fraction of patients.
The investigators expect, that atezolizumab in addition to chemotherapy is feasible in
patients with stage IV SCLC and reduced performance status and therefore crucial efficacy
data can be acquired in this trial to evaluate a putative Phase III transition in this
particular patient population.