NCT07055581RecruitingPhase 2
Durvalumab as Consolidation for Patients LS-SCLC
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)
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
Small-Cell Lung Cancer (SCLC) accounts for 10% to 15% of new lung cancers and is a highly aggressive neuroendocrine tumor. In the past 30 years, the treatment of SCLC has made very limited progress, and basically made breakthroughs in radiotherapy and chemotherapy. With the advent of the immune era, immunotherapy has achieved initial results in the treatment of SCLC. Approximately one-third of patients with small cell lung cancer are in limited-stage (LS-SCLC) disease at first diagnosis. Except for a very small number of patients with T1-2N0 who can be treated with surgery or stereotactic radiation therapy (SBRT), the standard treatment for the rest of the patients with LS-SCLC is concurrent chemoradiotherapy. The ORR of platinum-combined etoposide regimen combined with thoracic radiotherapy in LS-SCLC can reach 70% to 90%, and the median OS is 16-24 months, which significantly improves the survival of patients. Although many measures have been taken in the treatment of LS-SCLC, only 20% of LS-SCLC can be cured, and most patients have relapse and metastasis after treatment. This study is a single arm phase II preliminary pilot study, aim to assess the efficacy and safety of durvalumab combined with EP prior to CRT and followed by durvalumab consolidation therapy for LS-SCLC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 17 Jun 2025
- Start date
- Feb 2026
- Primary completion date
- Jul 2029
- Lead sponsor
- Qian Chu
- Diseases
- Lung cancer
- NCT number
- NCT07055581
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From Feb 2026 to the primary completion date, Jul 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 2.Patients who previously received radiotherapy to the thorax or chemotherapy for small cell lung cancer.
- 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.
- 7.Active or prior documented autoimmune or inflammatory disorders.
- 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.
Other illness
- 1.Patients with extensive disease small-cell lung cancer.
- 6.History of allogenic organ transplantation.
- 8.Uncontrolled intercurrent illness.
- 9.History of leptomeningeal carcinomatosis.
- 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.
- 15.Known allergy or hypersensitivity to IP or any excipient.
Lab values
- 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.
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.