---
title: Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC
nct_id: NCT03402464
overall_status: UNKNOWN
phase: PHASE2
sponsor: Peking University Cancer Hospital & Institute
study_type: INTERVENTIONAL
primary_condition: EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03402464.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03402464"
ct_last_update_post_date: 2018-01-18
last_seen_at: "2026-05-12T06:35:45.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC

**Official Title:** Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced Gradually Progressed NSCLC After First-line Icotinib: an Open-label, Single-arm, Multicenter Phase II Study

**NCT ID:** [NCT03402464](https://clinicaltrials.gov/study/NCT03402464)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Peking University Cancer Hospital & Institute
- **Collaborators:** Betta Pharmaceuticals Co., Ltd.
- **Conditions:** EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma
- **Start Date:** 2018-01
- **Completion Date:** 2020-09-20
- **CT.gov Last Update:** 2018-01-18

## Brief Summary

The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment.

## Eligibility

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

```
Inclusion Criteria:

1. Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy
2. Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Sensitive EGFR gene mutation(19/21)
5. Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation

Exclusion Criteria:

1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
2. Female subjects should not be pregnant or breast-feeding
3. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
4. Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc)
5. Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination
```

## Arms

- **Icotinib combined dihydroaremisinin** (EXPERIMENTAL)

## Interventions

- **Icotinib combined dihydroaremisinin** (DRUG) — Icotinib should be taken by the patients continuously until disease progressed or intolerable toxicity. On day 1-3, oral dihydroaremisinin was given at 20mg per day, the dose of dihydroaremisinin is increased to 40mg daily on day 4 to 6, and 80mg twice daily until disease progressed or intolerable toxicity.

## Primary Outcomes

- **Progress Free Survival** _(time frame: 18 months)_
- **Objective response rate** _(time frame: 18 months)_

## Secondary Outcomes

- **Overall Survival** _(time frame: 24 months)_

## Locations (1)

- Beijing Cancer Hospital, Beijing, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — 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)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beijing cancer hospital|beijing||china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03402464*  
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