Extensive-stage Small Cell Lung Cancer (SCLC)NCT07390565
YSQTG Combined With Immuno-chemotherapy for Extensive-Stage Small Cell Lung Cancer
A study testing Yishen Qutong Granules and Yishen Qutong Simulant Granules in people with Extensive-stage Small Cell Lung Cancer (SCLC), run by LI FENG at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer (SCLC)
- What is being tested?
- Yishen Qutong Granules and Yishen Qutong Simulant Granules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets Western medical diagnostic criteria for extensive-stage small cell lung cancer and Chinese medicine diagnostic criteria for kidney deficiency with qi deficiency and stagnation of blood stasis;
- Newly diagnosed extensive-stage small cell lung cancer patients who have not previously received Western medical antineoplastic therapy, with evaluable lesions;
- Intended to receive ≥2 cycles of first-line immunotherapy plus platinum-based chemotherapy plus etoposide;
- No concurrent or prior history of other primary malignancies;
- Aged ≥18 years with an estimated survival period of ≥3 months;
- Karnofsky Performance Status (KPS) ≥60 points;
- Normal cognitive function sufficient to complete questionnaires;
- Voluntary acceptance of the study treatment regimen and signing of informed consent.
Who cannot join
- Pregnant or breastfeeding women, or individuals with severe diseases affecting the cardiovascular, pulmonary, hepatic, renal, or haematological systems;
- Participants in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College
Beijing, Chaoyang, 100021
About this study
Official title: Yishen Qutong Granules Combined With Immunochemotherapy for Extensive-Stage Small Cell Lung Cancer: A Multicentre, Randomised, Triple-Blind, Placebo-Controlled 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.
- Being tested
- Yishen Qutong Granules, Yishen Qutong Simulant Granules
- Keywords
- Traditional Chinese Medicine, Western Medicine
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yishen Qutong GranulesDrug
The patent prescription of Professor Feng Li, the head of the Department of Traditional Chinese Medicine at the Cancer Hospital of the Chinese Academy of Medical Sciences.
Yishen Qutong Simulant GranulesDrug
Yishen Qutong Simulant Granules is a preparation with one-tenth the dosage of Yishen Qutong Granules.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Yishen Qutong Granules |
| 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. Receives: Drug: Yishen Qutong Simulant Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate（DCR）
Disease Control Rate (DCR) = (Complete Response + Partial Response + Stable Disease) /Total Number of Patients × 100%
Measured: 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 outcomes (9)
Overall Survival（OS）
The period from the commencement of treatment until the patient's death from any cause
Measured: Before treatment commencement; 21 days after commencement; 43 days after; 90 days after; 133 days after; 233 days after; 365 days after; 450 days after; 540 days after
progression-free survival（PFS）
Time from study entry to first radiographic evidence of tumour progression
Measured: Before treatment commencement; 21 days after commencement; 43 days after; 90 days after; 133 days after; 233 days after; 365 days after; 450 days after; 540 days after
Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine
The TCM Syndrome Score evaluates the severity of symptoms related to nodule accumulation, localized pain, tongue appearance, lumbar debility, and fatigue. Each symptom is scored from 0 to 6, with higher scores indicating more severe symptoms. The total score is the sum of individual symptom scores, reflecting the overall severity of TCM syndromes.
Measured: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Quality of Life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a 30-item questionnaire evaluating cancer patients' quality of life across multiple dimensions, including physical, emotional, cognitive, and social functioning, as well as symptom burden (e.g., fatigue, pain, nausea). Scores range from 0 to 100, with higher scores in functional scales and global health status indicating better quality of life, and higher scores in symptom scales indicating worse symptoms.
Measured: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
St George' s Respiratory Questionnaire (SGRQ)
The St George's Respiratory Questionnaire (SGRQ) is a standardised self-assessment tool used to evaluate the quality of life in patients with chronic respiratory diseases. By quantifying the impairment experienced by patients in terms of symptoms, functional capacity, and psychosocial adjustment, it comprehensively reflects the impact of the disease on patients' daily lives.
Scale Range and Interpretation Total score range: 0 to 100. Higher scores indicate greater impairment of health-related quality of life due to respiratory symptoms.
Measured: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Fatigue-Related Quality of Life (FACIT-F scale)
Cancer-related fatigue was assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale.
Scale Range and Interpretation Total score range: 0 to 52. Higher scores indicate better fatigue-related quality of life (i.e., less fatigue and its impact).
Measured: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Brief Fatigue Inventory scale (BFI scale)
Fatigue severity was assessed using the Brief Fatigue Inventory (BFI) scale. Scale Range and Interpretation Total score range: 0 to 10. Higher scores indicate more severe fatigue.
Measured: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
Anxiety was assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A).
Scale Range and Interpretation Total score range: 0 to 21. Higher scores indicate more severe anxiety symptoms.
Measured: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
Depression was assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D).
Scale Range and Interpretation Total score range: 0 to 21. Higher scores indicate more severe depressive symptoms.
Measured: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start17 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Extensive-stage Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LI FENG
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Cancer Hospital, Fudan University, Shanxi Province Cancer Hospital
- Responsible party
- Sponsor-investigator, LI FENG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390565
- Sponsor's protocol ID
- 2025YFC3508301
- Status last verified
- Jul 2025
- First submitted
- 22 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The project involves some patents that will not be disclosed at this time.
Publications
Qin K, Gay CM, Byers LA, Zhang J. The current and emerging immunotherapy paradigm in small-cell lung cancer. Nat Cancer. 2025 Jun;6(6):954-966. doi: 10.1038/s43018-025-00992-5. Epub 2025 Jun 5.
PubMed 40473974Xie M, Vuko M, Rodriguez-Canales J, Zimmermann J, Schick M, O'Brien C, Paz-Ares L, Goldman JW, Garassino MC, Gay CM, Heymach JV, Jiang H, Barrett JC, Stewart RA, Lai Z, Byers LA, Rudin CM, Shrestha Y. Molecular classification and biomarkers of outcome with immunotherapy in extensive-stage small-cell lung cancer: analyses of the CASPIAN phase 3 study. Mol Cancer. 2024 May 30;23(1):115. doi: 10.1186/s12943-024-02014-x.
PubMed 38811992Shields MD, Chiang AC, Byers LA. Top advances of the year: Small cell lung cancer. Cancer. 2025 Mar 15;131(6):e35770. doi: 10.1002/cncr.35770.
PubMed 40040254Zugazagoitia J, Paz-Ares L. Extensive-Stage Small-Cell Lung Cancer: First-Line and Second-Line Treatment Options. J Clin Oncol. 2022 Feb 20;40(6):671-680. doi: 10.1200/JCO.21.01881. Epub 2022 Jan 5.
PubMed 34985925Chen Y, Li H, Fan Y. Shaping the tumor immune microenvironment of SCLC: Mechanisms, and opportunities for immunotherapy. Cancer Treat Rev. 2023 Nov;120:102606. doi: 10.1016/j.ctrv.2023.102606. Epub 2023 Aug 7.
PubMed 37579532Zhu L, Qin J. Predictive biomarkers for immunotherapy response in extensive-stage SCLC. J Cancer Res Clin Oncol. 2024 Jan 20;150(1):22. doi: 10.1007/s00432-023-05544-x.
PubMed 38245636Tomic K, Vranic S. Small cell lung cancer (SCLC): At the door of targeted therapies. Biomol Biomed. 2025 Aug 29;26(1):1-4. doi: 10.17305/bb.2025.13195.
PubMed 40884462Kim SY, Park HS, Chiang AC. Small Cell Lung Cancer: A Review. JAMA. 2025 Jun 3;333(21):1906-1917. doi: 10.1001/jama.2025.0560.
PubMed 40163214
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yishen Qutong Granules Combined With Immunochemotherapy for Extensive-Stage Small Cell Lung Cancer: A Multicentre, Randomised, Triple-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07390565
- Acronym / sponsor ID
- 2025YFC3508301
- Keywords
- Traditional Chinese Medicine, Western Medicine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- LI FENGUniversity, hospital or other
- Collaborators
- Henan Cancer Hospital, Fudan University, Shanxi Province Cancer Hospital
- Study start
- 17 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group(Yishen Qutong Granules) | Experimental | Drug: Yishen Qutong GranulesYishen 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 | Drug: Yishen Qutong Simulant GranulesIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meets Western medical diagnostic criteria for extensive-stage small cell lung cancer and Chinese medicine diagnostic criteria for kidney deficiency with qi deficiency and stagnation of blood stasis;
- Newly diagnosed extensive-stage small cell lung cancer patients who have not previously received Western medical antineoplastic therapy, with evaluable lesions;
- Intended to receive ≥2 cycles of first-line immunotherapy plus platinum-based chemotherapy plus etoposide;
- No concurrent or prior history of other primary malignancies;
- Aged ≥18 years with an estimated survival period of ≥3 months;
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women, or individuals with severe diseases affecting the cardiovascular, pulmonary, hepatic, renal, or haematological systems;
- Participants in other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yishen Qutong GranulesThe patent prescription of Professor Feng Li, the head of the Department of Traditional Chinese Medicine at the Cancer Hospital of the Chinese Academy of Medical Sciences. | Drug | Treatment group(Yishen Qutong Granules) |
| Yishen Qutong Simulant GranulesYishen Qutong Simulant Granules is a preparation with one-tenth the dosage of Yishen Qutong Granules. | Drug | Control group(Placebo) |
Primary outcome
Disease Control Rate（DCR）
Time frame: 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.
Disease Control Rate (DCR) = (Complete Response + Partial Response + Stable Disease) /Total Number of Patients × 100%
9 secondary outcomes
Overall Survival（OS）
Time frame: Before treatment commencement; 21 days after commencement; 43 days after; 90 days after; 133 days after; 233 days after; 365 days after; 450 days after; 540 days after
progression-free survival（PFS）
Time frame: Before treatment commencement; 21 days after commencement; 43 days after; 90 days after; 133 days after; 233 days after; 365 days after; 450 days after; 540 days after
Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Quality of Life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
St George' s Respiratory Questionnaire (SGRQ)
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Fatigue-Related Quality of Life (FACIT-F scale)
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Brief Fatigue Inventory scale (BFI scale)
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 40473974Qin K, Gay CM, Byers LA, Zhang J. The current and emerging immunotherapy paradigm in small-cell lung cancer. Nat Cancer. 2025 Jun;6(6):954-966. doi: 10.1038/s43018-025-00992-5. Epub 2025 Jun 5.
- Results publication: PubMed 38811992Xie M, Vuko M, Rodriguez-Canales J, Zimmermann J, Schick M, O'Brien C, Paz-Ares L, Goldman JW, Garassino MC, Gay CM, Heymach JV, Jiang H, Barrett JC, Stewart RA, Lai Z, Byers LA, Rudin CM, Shrestha Y. Molecular classification and biomarkers of outcome with immunotherapy in extensive-stage small-cell lung cancer: analyses of the CASPIAN phase 3 study. Mol Cancer. 2024 May 30;23(1):115. doi: 10.1186/s12943-024-02014-x.
- Results publication: PubMed 40040254Shields MD, Chiang AC, Byers LA. Top advances of the year: Small cell lung cancer. Cancer. 2025 Mar 15;131(6):e35770. doi: 10.1002/cncr.35770.
- Results publication: PubMed 34985925Zugazagoitia J, Paz-Ares L. Extensive-Stage Small-Cell Lung Cancer: First-Line and Second-Line Treatment Options. J Clin Oncol. 2022 Feb 20;40(6):671-680. doi: 10.1200/JCO.21.01881. Epub 2022 Jan 5.
- Results publication: PubMed 37579532Chen Y, Li H, Fan Y. Shaping the tumor immune microenvironment of SCLC: Mechanisms, and opportunities for immunotherapy. Cancer Treat Rev. 2023 Nov;120:102606. doi: 10.1016/j.ctrv.2023.102606. Epub 2023 Aug 7.
- Results publication: PubMed 38245636Zhu L, Qin J. Predictive biomarkers for immunotherapy response in extensive-stage SCLC. J Cancer Res Clin Oncol. 2024 Jan 20;150(1):22. doi: 10.1007/s00432-023-05544-x.
- Results publication: PubMed 40884462Tomic K, Vranic S. Small cell lung cancer (SCLC): At the door of targeted therapies. Biomol Biomed. 2025 Aug 29;26(1):1-4. doi: 10.17305/bb.2025.13195.
- Results publication: PubMed 40163214Kim SY, Park HS, Chiang AC. Small Cell Lung Cancer: A Review. JAMA. 2025 Jun 3;333(21):1906-1917. doi: 10.1001/jama.2025.0560.
- Individual participant dataSharing planned: No. The project involves some patents that will not be disclosed at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yishen Qutong Granules and Yishen Qutong Simulant Granules in people with Extensive-stage Small Cell Lung Cancer (SCLC), run by LI FENG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate（DCR） (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07390565, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.