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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: qchu@hust.edu.cn
• Phone: 86-15392852671

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer

  This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Gang-Nam · NCT07911280

• Durvalumab with FLOT before and after surgery for resectable gastric/GEJ cancer in Chinese patients

  This trial tests whether adding durvalumab to FLOT chemotherapy before and after surgery helps Chinese patients with resectable gastric or gastroesophageal junction cancer.

  Recruiting at 11 sites Phase 3 AstraZeneca · Beijing and 40 other locations · NCT07877818

• Zolbetuximab added to FLOT and durvalumab before surgery for CLDN18.2-positive gastric/GEJ cancer

  This study tests whether adding zolbetuximab to FLOT chemotherapy plus durvalumab can improve tumor response before surgery in adults with CLDN18.2-positive gastric or GEJ cancer.

  Recruiting Phase 2 National Cancer Center, Japan · Saitama and 3 other locations · NCT07872722

• Alternating chemo-immunotherapy and FGFR inhibitor for FGFR-positive biliary tract cancer

  This phase 2 trial tests whether alternating gemcitabine/cisplatin with durvalumab and the FGFR2 inhibitor pemigatinib can help people with unresectable or metastatic biliary tract cancers that have FGFR alterations.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07780838

• Durvalumab plus histotripsy for intrahepatic cholangiocarcinoma

  This study tests whether adding histotripsy to ongoing durvalumab helps people with advanced intrahepatic cholangiocarcinoma by boosting the immune response and checking safety.

  Recruiting Phase 2 University of Wisconsin, Madison · Madison, Wisconsin · NCT07766187

• Futibatinib and immunotherapy with chemo as first-line treatment for advanced biliary tract cancer

  A first-line treatment test combines Futibatinib with Zimberelimab and Gemcitabine/Cisplatin to see if it improves survival in people with unresectable or advanced biliary tract cancer.

  Recruiting at 4 sites Phase 3 Taiho Pharmaceutical Co., Ltd. · Brisbane and 20 other locations · NCT07710885

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.