Durvalumab consolidation after chemoradiotherapy for limited-stage small cell lung cancer

A Phase II Study of Durvalumab Combined With EP Prior to Chemoradiotherapy and Followed by Durvalumab as Consolidation for Patients With Limited-stage Small-cell Lung Cancer (CONCUR Study)

This trial tests whether giving durvalumab alongside and after standard chemoradiotherapy helps people with limited-stage small cell lung cancer have better tumor control and longer survival.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: durvalumab, chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Zhengzhou, Henan and 1 other locations)
• Trial ID: NCT07055581 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial combines durvalumab with standard etoposide/platinum chemotherapy and thoracic radiotherapy, followed by durvalumab maintenance, for patients with limited-stage small cell lung cancer (stage I-III, M0). Eligible participants are adults with histologically confirmed SCLC, ECOG 0-1, adequate organ function, and at least one measurable lesion. The regimen aims to improve response rates and extend progression-free and overall survival compared with historical outcomes from chemoradiotherapy alone. Study treatment and follow-up visits are conducted at participating cancer centers in Zhengzhou and Wuhan, China.

Who should consider this trial

Good fit: Adults with pathologically confirmed limited-stage (stage I-III, M0) small cell lung cancer, ECOG performance status 0–1, adequate organ function, and at least one RECIST-measurable lesion who have not received prior thoracic radiotherapy are the intended participants.

Not a fit: Patients with extensive-stage disease, prior thoracic radiotherapy, ECOG ≥2, significant organ dysfunction, or other exclusionary conditions are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding durvalumab could extend the time patients live without disease progression and improve overall survival compared with standard chemoradiotherapy alone.

How similar studies have performed: Immune checkpoint inhibitors have shown survival benefit in extensive-stage SCLC and early activity in SCLC overall, but consolidation durvalumab specifically in limited-stage disease is less established and remains under study.

Eligibility criteria

Inclusion Criteria:

* 1.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* 2.Histologically or cytologically confirmed small cell lung cancer
* 3.Limited-stage, defined as stage I-III SCLC (T any, N any, M0). Patients who are Stage I or II must be medically inoperable as determined by investigator.
* 4.Age \> 18 years.
* 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 6.Adequate normal organ and marrow function.
* 7.Must have a life expectancy of at least 12 week.
* 8.At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to enrollment.

Exclusion Criteria:

* 1.Patients with extensive disease small-cell lung cancer.
* 2.Patients who previously received radiotherapy to the thorax or chemotherapy for small cell lung cancer.
* 3.Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology. Patients with mixed histology tumors with predominant SCLC histology are allowed.
* 4.Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values.
* 5.Any concurrent chemotherapy other than study treatment, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
* 6.History of allogenic organ transplantation.
* 7.Active or prior documented autoimmune or inflammatory disorders.
* 8.Uncontrolled intercurrent illness.
* 9.History of leptomeningeal carcinomatosis.
* 10.Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)
* 11.History of active primary immunodeficiency
* 12.Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of antiHBc and absence of HBsAg) and with undetectable HBV DNA (\< 10 IU/ml or under the limit of detection per local lab standard) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
* 13.Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
* 14.Prior treatment in a previous durvalumab clinical study.
* 15.Known allergy or hypersensitivity to IP or any excipient.

Where this trial is running

Zhengzhou, Henan and 1 other locations

• The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Qian Chu, Head of the Thoracic Cancer De

Conditions Small Cell Lung Cancer Limited Stage; small cell lung cancer