NCT07928882

Clinical Study on Fuzheng Jiedu Huayu Therapy in Combination With Chemotherapy and Immunotherapy for Improving Survival Rates in Extensive-Stage Small Cell Lung Cancer

StatusNot Yet Recruiting

PhaseNot applicable

SponsorLI FENG

Primary completionDec 31, 2027 (estimated)

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Record History

All 1 version: 1 with changes below.

Nov 4, 2026 Study First Submitted

Endpoints

Primary

Objective Response Rate, ORR

Timeframe: The patient underwent a chest CT scan every two treatment cycles to evaluate antitumor efficacy.

Secondary (10)

Numerical Rating Scale

QLQ-C30 scale point

Overall Survival, OS

Cancer-related fatigue state

Physical Condition Score

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Emotional state

progression-free survival，PFS

Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine

Assess the impact of lung disease on patients

Tumor markers

Arms and interventions

Treatment group(Yishen Qutong Granules)Experimental

Yishen Qutong Granules administered at 10g per dose, three times daily, in conjunction with immunotherapy plus etoposide and platinum-based first-line treatment.

Control group(Placebo)Placebo comparator

In parallel with immunotherapy plus etoposide and platinum-based first-line treatment, administer a simulated formulation of Yishen Qutong Granules (1/10 Yishen Qutong Granules), 10g per dose, three times daily.

Drugs: Yishen Qutong Granules, Yishen Qutong Simulant Granules

Sites

3 sites in 1 country

About this trial

Small cell lung cancer (SCLC) is a highly aggressive neuroendocrine malignancy. Approximately 70% of patients are diagnosed with extensive-stage disease, and only a subset of patients benefit from immunotherapy. Under the leadership of Academician Sun Yan, the principal investigator, our research group previously relied on the Big Data Platform of the National Cancer Center and undertook major projects including those from the National Administration of Traditional Chinese Medicine, the Beijing Administration of Traditional Chinese Medicine for collaborative of major and difficult diseases with integrated traditional Chinese and Western medicine, as well as the National Key R\&D Program. A randomized controlled trial (RCT) of 600 cases demonstrated that the traditional Chinese medicine "Fuzheng Jiedu Huayu" (strengthening vital energy, detoxifying, and resolving stasis) combined with chemotherapy and immunotherapy synergistically improved progression-free survival and disease control rate in patients with extensive-stage SCLC. Building on this foundation, the current project will enroll 224 patients with extensive-stage SCLC (1:1 ratio). On the basis of first-line treatment with immunotherapy plus platinum-based agents and etoposide, patients will be administered either "Fuzheng Jiedu Huayu" traditional Chinese medicine or a placebo. The study will employ objective response rate, progression-free survival, and overall survival as outcome measures, conducting a multicenter, large-sample RCT. Additionally, a multimodal database of no less than 1000 cases will be established, striving to obtain an IND approval, thereby contributing to the realization of the goal set forth in the "Healthy China 2030" Planning Outline: "By 2030, increase the overall 5-year cancer survival rate by 15%."

Trial details

Enrollment: 224 participants (estimated)
Started: Jan 1, 2027
Study completion: Dec 31, 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, triple blind, treatment
Oversight: Data monitoring committee
Conditions: Small Cell Lung Carcinoma, SCLC, Extensive Stage
Collaborators: Beijing Chest Hospital, Capital Medical University, Peking University Cancer Hospital & Institute
First posted: Nov 10, 2026
Registry updated: Nov 10, 2026
Last verified: Oct 2026

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