A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer

April 2, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

An Open Label, Multicenter Phase II Clinical Study on the Safety, Tolerability, and Efficacy of FH-006 Injection Combined With Other Anti-tumor Therapies in Lung Cancer Subjects

Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in combination with other anti-tumor treatments in lung cancer subjects, and determine the recommended dose (RP2D) and initial efficacy for phase II clinical trials.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • Li Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age range: 18-75 years old (including both ends), gender is not limited.
  2. Subjects with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology as unsuitable for radical surgery or radiotherapy treatment
  3. ECOG score is 0 or 1
  4. Expected survival period ≥ 12 weeks
  5. According to the RECIST v1.1 standard, there must be at least one measurable lesion.
  6. Good level of organ function
  7. The patient voluntarily joined this study and signed informed consent
  8. Left ventricular ejection fraction (LVEF) ≥ 50%

Exclusion Criteria:

  1. Suffering from other malignant tumors within the past 5 years
  2. Subjects with active central nervous system (CNS) tumor metastasis, a history of meningeal metastasis, or current meningeal metastasis
  3. Patients with uncontrollable tumor related pain
  4. Has serious cardiovascular and cerebrovascular diseases
  5. Significant clinically significant bleeding symptoms occurred within 3 months prior to the first study medication
  6. Uncontrollable third interstitial fluid accumulation within 2 weeks of initial study medication
  7. History of clinically significant pulmonary diseases
  8. Receive other anti-tumor treatments within 4 weeks before the first medication
  9. Severe infection within 4 weeks before the first medication
  10. Active, known or suspected autoimmune diseases, and a history of autoimmune diseases.
  11. History of immunodeficiency
  12. Individuals with active pulmonary tuberculosis infection within the year prior to enrollment
  13. Chest radiation therapy patients who received>30 Gy within 24 weeks prior to the first use of the investigational drug
  14. The adverse reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade I
  15. Surgical treatment of important organs within 4 weeks prior to the first use of medication
  16. Use attenuated live vaccine within 28 days prior to the first use of the investigational drug
  17. There are other serious physical or mental illnesses or laboratory abnormalities present
  18. Pregnant, lactating women, or female participants who plan to become pregnant within 14 months after the last use of the investigational drug during the study period
  19. Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency
  20. Previously experienced hypertensive crisis or hypertensive encephalopathy
  21. Suffering from significant vascular disease within 6 months prior to the first use of medication
  22. Have undergone a biopsy or other minor surgery within 7 days prior to the first use of medication
  23. Having severe, unhealed wounds, active ulcers, or untreated fractures
  24. Gastrointestinal perforation occurred within 6 months prior to the first use of medication
  25. 24-hour proteinuria quantification ≥ 1g within 7 days before the first medication
  26. CT/MRI indicates tumor surrounding or invading large blood vessels

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A
Drug: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
Experimental: Part B
Drug: FH-006 ; SHR-1316 ; BP102
FH-006 ; SHR-1316 ; BP102
Experimental: Part C
Drug: FH-006; SHR-1316 ; SHR-8068
FH-006; SHR-1316 ; SHR-8068

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment.
Time Frame: 21or28 days after the first administration of each subject
21or28 days after the first administration of each subject
Incidence of Treatment-Emergent Adverse Events
Time Frame: from first dose to disease progression or death, up to 3 years.
from first dose to disease progression or death, up to 3 years.
RP2D (Recommended Phase II Dose)：This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.
Time Frame: from first dose to disease progression or death, up to 3 years
This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.
from first dose to disease progression or death, up to 3 years
ORR (Objective Response Rate)
Time Frame: from first dose to disease progression or death, whichever comes first, up to 3 years
The proportion of patients whose tumor volume shrank to the pre-defined standard (complete or partial response) after treatment.
from first dose to disease progression or death, whichever comes first, up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of response (DoR)
Time Frame: from first dose to disease progression or death, whichever comes first, up to 3 years
from first dose to disease progression or death, whichever comes first, up to 3 years
disease control rate (DCR)
Time Frame: from first dose to disease progression or death, whichever comes first, up to 3 years
from first dose to disease progression or death, whichever comes first, up to 3 years
progression free survival (PFS)
Time Frame: from first dose to disease progression or death, whichever comes first, up to 3 years
from first dose to disease progression or death, whichever comes first, up to 3 years
overall survival (OS)
Time Frame: from first dose to disease progression or death, whichever comes first, up to 3 years
from first dose to disease progression or death, whichever comes first, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FH-006-201-LC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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