---
title: Safety and Exploratory Efficacy of Kanglaite Injection in Non Small Cell Lung Cancer
nct_id: NCT01640730
overall_status: TERMINATED
phase: PHASE2
sponsor: KangLaiTe USA
study_type: INTERVENTIONAL
primary_condition: Stage IV NSCLC
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01640730.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01640730"
ct_last_update_post_date: 2014-01-16
last_seen_at: "2026-05-12T06:30:40.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Exploratory Efficacy of Kanglaite Injection in Non Small Cell Lung Cancer

**Official Title:** An Open Label Safety and Exploratory Efficacy Study of Kanglaite Injection in Patients Having Progressive Stage IV NSCLC Who Are Not Candidates for Other Anti-cancer Treatment

**NCT ID:** [NCT01640730](https://clinicaltrials.gov/study/NCT01640730)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** poor enrollment
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1
- **Lead Sponsor:** KangLaiTe USA
- **Conditions:** Stage IV NSCLC
- **Start Date:** 2012-05
- **Completion Date:** 2012-10
- **CT.gov Last Update:** 2014-01-16

## Brief Summary

This study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* confirmed (within last 3 months)progressive Stage IV NSCLC
* estimated life span of 3 months
* phase angle of at least 5 as measured by bioimpedance

Exclusion Criteria:

* currently taking a lipid lowering medications
* has an imminently life threatening condition
* has pre-existing liver disease
* known allergy to soybeans
* uncontrolled diabetes or uncontrolled disturbance of lipid metabolism
* pregnant or lactating
* has a pacemaker or other implantable electronic medical device
```

## Arms

- **Kanglaite injection** (EXPERIMENTAL)

## Interventions

- **Kanglaite Injection** (DRUG) — 30gm IV infusion 5 days a week for 3 weeks every 28 days

## Primary Outcomes

- **Overall Survival** _(time frame: from date of enrollment until date of death from any cause assessed up to 12 months)_

## Secondary Outcomes

- **Bioimpedance Phase Angle** _(time frame: measured each month up to one year)_
- **Palliation Response Measure** _(time frame: each month up to one year)_

## Locations (1)

- The West Clinic, Memphis, Tennessee, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the west clinic|memphis|tennessee|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01640730.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01640730*  
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