---
title: A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
nct_id: NCT04884009
overall_status: UNKNOWN
phase: PHASE2
sponsor: Jiangsu HengRui Medicine Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Lung Cancer
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04884009.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04884009"
ct_last_update_post_date: 2021-05-12
last_seen_at: "2026-05-12T06:36:43.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer

**Official Title:** An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure

**NCT ID:** [NCT04884009](https://clinicaltrials.gov/study/NCT04884009)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 106
- **Lead Sponsor:** Jiangsu HengRui Medicine Co., Ltd.
- **Conditions:** Lung Cancer
- **Start Date:** 2021-05-31
- **Completion Date:** 2022-12-31
- **CT.gov Last Update:** 2021-05-12

## Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
2. 18 to 75 years old, male or female.
3. Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）.
4. ECOG Performance Status of 0 or 1.
5. Adequate hematological, hepatic and renal function.
6. Female subjects of child-bearing potential must have a negative serum HCG test before treatment.

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
2. Untreated central nervous system metastases.
3. Cancerous meningitis (meningeal metastasis).
4. Uncontrolled pleural effusion, pericardial effusion or ascites.
5. Tumor infiltration into the great vessels on imaging;
6. Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month.
7. Uncontrolled tumor-related pain.
8. Malignancies other than SCLC within 5 years.
9. Systemic antitumor therapy was received 4 weeks prior to trial treatment.
10. History of autoimmune diseases.
11. Significant cardiovascular disease.
12. Inadequately controlled hypertension.
13. Known history of testing positive test for HIV or known AIDS.
14. Patients with active hepatitis B or hepatitis C
15. Severe infections within 4 weeks prior to trial treatment.
16. Active tuberculosis.
```

## Arms

- **SHR-1701+ Famitinib** (EXPERIMENTAL)
- **SHR-1701** (EXPERIMENTAL)

## Interventions

- **SHR-1701； Famitinib** (DRUG) — SHR-1701+ Famitinib
- **SHR-1701** (DRUG) — SHR-1701

## Primary Outcomes

- **Objective response rate (ORR) based on RECIST 1.1 criteria** _(time frame: up to approximately 1 year.)_

## Secondary Outcomes

- **Progression free survival (PFS) based on RECIST 1.1 criteria** _(time frame: up to approximately 1 year.)_
- **Disease control rate (DCR) based on RECIST 1.1 criteria** _(time frame: up to approximately 1 year.)_
- **Duration of response (DoR)** _(time frame: up to approximately 1 year)_
- **Overall survival (OS)** _(time frame: up to approximately 1 year)_
- **AEs+ SAEs determined by NCI-CTCAE V5.0** _(time frame: Baseline until up to 90 days after end of treatment.)_

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `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.maxAge` — 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)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04884009.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04884009*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*