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Post-marketing, Prospective Cohort Study on the Efficacy and Safety of Kanglaite Soft Capsules for Maintenance Treatment of Non-Small Cell Lung Cancer After First-Line Chemotherapy

Post-marketing, Prospective Cohort Study on the Efficacy and Safety of Kanglaite Soft Capsules for Maintenance Treatment of Non-Small Cell Lung Cancer After First-Line Chemotherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025002314
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Unexposed Group:No Intervention

Sponsors

Guang'anmen Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Have at least one measurable lesion defined in accordance with the RECIST Version 1.1 criteria. 2.ECOG performance status score = 2, with an expected survival of more than 3 months. 3.Achieve stable disease after receiving first-line chemotherapy for = 4 cycles; and before enrollment, the adverse events occurring during chemotherapy (except alopecia) have been assessed by the investigator as recovered to Grade 1 in accordance with CTCAE. 4.Have a score of = 5 in at least one of the following items (pain, fatigue, poor appetite) in the MD Anderson Symptom Inventory - Lung Cancer Module (MDASI-LC). 5.Patients who do not receive radiotherapy. 6.Aged 18 - 80 years old. 7.Voluntarily participate in this study.

Exclusion criteria

Exclusion criteria: No

Design outcomes

Primary

MeasureTime frame
Functional Assessment of Cancer Therapy-Lung;

Secondary

MeasureTime frame
ECOG Performance Status Scale;MD Anderson Symptom Inventory-Lung Cancer module;Proportion of adverse reactions of CTCAE grade =3 among anti-tumor toxic and side effects during treatment;Progression-Free Survival (PFS) during treatment;Objective Response Rate (ORR) during treatment;Disease Control Rate (DCR) during treatment.;Overall Survival (OS) during the observation period;

Countries

People's Republic of China

Contacts

Public ContactJie LI

Guang'anmen Hospital China Academy of Chinese Medical Sciences

793116750@qq.com+86 13195867479

Outcome results

None listed

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