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A multi-center prospective randomized controlled study on traditional Chinese medicine combined with ICIs in the treatment of driver gene-negative advanced non-small cell lung cancer

A multi-center prospective randomized controlled study on traditional Chinese medicine combined with ICIs in the treatment of driver gene-negative advanced non-small cell lung cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001937
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-06-12
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

control group:first-line chemotherapy combined with ICIs
experimental group:Jinfukang Oral Liquid + First-line chemotherapy combined with ICIs

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Confirmed as advanced NSCLC (stage IIIB–IV) by histopathological and/or cytological examination with at least one measurable and evaluable target lesion; No prior first-line anti-tumor treatment received; Negative for driver genes (EGFR mutation ALK fusion and ROS1 fusion are all negative); PD-L1 < 1%; Not suitable for chemotherapy combined with other systemic therapeutic drugs (including but not limited to anti-angiogenic targeted drugs) but eligible if receiving chemotherapy combined with radiotherapy; TCM syndrome differentiation consistent with qi-yin deficiency syndrome; Age = 18 years; Expected survival period = 3 months; Performance status score = 2; Voluntarily participate in the study with good compliance and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Known allergy to the ingredients of the study drug; Pregnant or lactating women; Multiple brain metastases multiple bone metastases or multiple liver metastases which are expected to have a significant impact on the patient's survival; Currently participating in other drug clinical trials; Refusal to cooperate with follow-up; Other reasons deemed by the researcher as making the patient unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
3-year survival rate;?Disease Control Rate?;TCM syndromes and symptoms;Adverse Event?;Quality of life ;1-year survival rate;Objective Response Rate?;

Countries

CHINA

Contacts

Public ContactLei ZHOU

Department of Oncology Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China

lucyzhou100@163.com13641759529

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026