NCT07390565

YSQTG Combined With Immuno-chemotherapy for Extensive-Stage Small Cell Lung Cancer

StatusRecruiting

PhaseNot applicable

SponsorLI FENG

Primary completionDec 31, 2027 (estimated)

At risk: Primary completion moved 12 months later.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 11, 2026 Primary completion pushed from Dec 31, 2026 to Dec 31, 2027 Show 6 more changesShow less
- Start date: Feb 17, 2026 to Dec 17, 2026
- Eligibility criteria expanded, about 10 words
- Trial status changed: Enrolling by Invitation → Recruiting
- Secondary endpoints: details revised at 8 of 9 entries
- Site details revised
- Publications: details revised at 8 of 8 entries
Minor Feb 5, 2026 Study title shortened, about 4 wordsv2
Jan 31, 2026 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Disease Control Rate（DCR）

Timeframe: Follow-up visits were conducted at 43 days, 90 days, 133 days, 233 days, 365 days (12 months), 450 days (15 months), and 540 days (18 months) after commencement, totalling seven visits.

Secondary (9)

Overall Survival（OS）

progression-free survival（PFS）

Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine

Quality of Life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

St George' s Respiratory Questionnaire (SGRQ)

Show 4 moreShow less

Fatigue-Related Quality of Life (FACIT-F scale)

Brief Fatigue Inventory scale (BFI scale)

Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)

Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)

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)Experimental

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

1 site in 1 country

Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical CollegeBeijing, Chaoyang, China

About this trial

Globally, lung cancer stands as the foremost cause of cancer-related mortality. Among its subtypes, small cell lung cancer (SCLC) represents an exceptionally aggressive malignancy, accounting for approximately 15-20% of all lung cancer cases. Over two-thirds of SCLC patients are diagnosed at an extensive stage, facing a median survival of only 7-12 months, a 2-year survival rate below 5%, and a dismal 5-year survival rate of 2%, underscoring its poor prognosis and high mortality. First-line treatment for extensive-stage SCLC typically involves comprehensive therapy centered on chemotherapy, often combined with immunotherapy. While this approach can achieve response rates of 50-70%, it is frequently accompanied by significant adverse effects, including bone marrow suppression and debilitating gastrointestinal reactions such as nausea, vomiting, and anorexia. The considerable toxicity associated with chemotherapy poses a major clinical challenge, limiting the potential for dose or duration escalation and hindering further efficacy gains. Therefore, developing strategies to mitigate toxicity while enhancing therapeutic efficacy remains an urgent clinical priority. In the paradigm of Traditional Chinese Medicine (TCM), extensive-stage SCLC is categorized under syndromes such as "pulmonary accumulation," "cough," and "consumptive disease." Its fundamental pathogenesis is characterized by a deficiency of healthy qi (vital energy) alongside an excess of pathogenic factors, primarily "toxins," "stasis," and "phlegm." The core pathological mechanism involves the internal accumulation of toxins, disruption of the lung's dispersing and descending functions, disharmony of qi and blood, and consequent depletion of vital qi over time. Treatment strategies thus aim to resolve toxins, dispel stasis, and reinforce the body's vital qi. Preliminary clinical observations suggest that the TCM formula Yishen Qutong Granules, developed based on the theories of "reinforcing healthy qi to resolve toxins" and the "metal-water mutual generation" principle, can significantly alleviate symptoms in SCLC patients. Building on this foundation, the present study proposes to evaluate the integration of Yishen Qutong Granules with standard chemo-immunotherapy for extensive-stage SCLC, with the objectives of improving patients' quality of life and extending overall survival. To this end, investigators will conduct a multicenter, randomized, triple-blind, placebo-controlled clinical trial. A total of 308 patients with extensive-stage SCLC, who are scheduled to undergo first-line immunotherapy combined with etoposide and platinum-based chemotherapy, will be enrolled from participating centers. Participants will be randomly allocated in a 1:1 ratio to either the treatment group or the control group (n=154 each). The treatment group will receive oral Yishen Qutong Granules (10g, three times daily) in addition to the standard chemo-immunotherapy regimen. The control group will receive an identical regimen of standard therapy along with a matched placebo granule. The intervention period for the herbal preparation/placebo is 90 days, and all patients will be followed for 18 months. The primary efficacy endpoint is the Disease Control Rate (DCR). Secondary endpoints include Overall Survival (OS), Progression-Free Survival (PFS), TCM syndrome score (assessed using a validated scale), St. George's Respiratory Questionnaire (SGRQ) score, EORTC QLQ-C30 quality of life score, cancer-related fatigue, and emotional status. Safety will be rigorously monitored through serial assessments of routine blood/urine/stool tests, hepatic and renal function panels, and electrocardiograms. This study aims to generate high-level evidence for the integrative TCM-Western medicine approach and elucidate the potential role of Yishen Qutong Granules in the comprehensive management of extensive-stage SCLC.

Trial details

Enrollment: 308 participants (estimated)
Started: Dec 17, 2026
Study completion: Jun 30, 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, Extensive-stage Small Cell Lung Cancer (SCLC)
Collaborators: Henan Cancer Hospital, Fudan University, Shanxi Province Cancer Hospital
Official title: Yishen Qutong Granules Combined With Immunochemotherapy for Extensive-Stage Small Cell Lung Cancer: A Multicentre, Randomised, Triple-Blind, Placebo-Controlled Trial
First posted: Feb 5, 2026
Registry updated: Nov 13, 2026
Last verified: Sep 2026

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