Clinical trial · Interventional
Clinical Trial of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT03986528CI-TRIAL-00050261unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Kanglaite Injection+Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Kanglaite Injection + Chemotherapy
- description
- Participants receive Kanglaite Injection PLUS first-line chemotherapy.
- interventionNames
- Drug: Kanglaite Injection+Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- first-line chemotherapy.
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Progression Free Survival(PFS)
- timeFrame
- Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * A Histological or cytological confirmed diagnosis of Stage III-IV NSCLC, with no history of anticancer treatment including chemotherapy; * Male or female aged 18-75years; * Eastern Cooperative Oncology Group (ECOG) performance score 0-2; * Life expectancy of at least 3 months; * At least one radiographically measurable lesion per RECIST 1.1; * Willing to join the clinic trail and sign informed consent; * Able to comply with scheduled visits and treatments. Exclusion Criteria: * Presence of cerebral metastases; * Confirmed positive for expression of expression of epidermal growth factor receptor (EGFR), activin receptor-like kinase (ALK), c-ros oncogene 1 (ROS1) mutation, or programmed death-ligand 1 (PD-L1)(tumor proportion score \[TPS≥ 50%\] in a genetic test; * Participants with malignant pleural effusion underwent intrapleural injection chemotherapy; * Current undergoing or preparing for treatment with target therapy; * Current undergoing or preparing for radiotherapy to the thorax; * Current undergoing or preparing treatment with tumor immunotherapy; * Currently undergoing lipid-decreasing treament; * Pregnant or breastfeeding woman; * Fertile patients who are unwilling or unable to take effective contraceptive measures during the research period until 6 months after the study end later; * A history of mental disorders; * Severe and uncontrolled organic lesion or infection, including but not limited to cardiopulmonary failure and renal failure,which lead to poor tolerance of chemotherapy; * Participated in other clinical trials of small molecule research drugs within 28 days prior to enrollment, or participated in other clinical trials of large molecule research drugs within 3 months before enrollment; * Known allergy or intolerance to study medications; * Considered to be otherwise unsuitable for the clinical study by researchers.
References
Publications (1)
- DERIVEDGao R, Zhang Y, Hou W, Li J, Zhu G, Zhang X, Xu B, Wu Z, Wang H. Combination of first-line chemotherapy with Kanglaite injections versus first-line chemotherapy alone for advanced non-small-cell lung cancer: study protocol for an investigator-initiated, multicenter, open-label, randomized controlled trial. Trials. 2021 Mar 17;22(1):214. doi: 10.1186/s13063-021-05169-w. PMID 33731199