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Non-squamous Non-small-cell Lung CancerPhase 3NCT04619433

A Study to Evaluate SHR-1210 in Combination With Famitinib Plus Chemotherapy in Subjects With NSCLC.

A Phase 3 study testing Camrelizumab;Pemetrexed and Carboplatin; Famitinib; in people with Non-squamous Non-small-cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 7 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study is being conducted to evaluate the efficacy and safety of SHR-1210 in combination with Famitinib plus chemotherapy in subjects with NSCLC. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-squamous Non-small-cell Lung Cancer
What is being tested?
Camrelizumab;Pemetrexed and Carboplatin; Famitinib;
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
7 sitesChina
Study dates
1 Feb 2021to 16 Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form, male or female, 18-70 years of age.
  • Histologically or cytologically confirmed, Stage IIIB-IV non-squamous NSCLC
  • EGFR mutation and ALK rearrangement status must be negative.
  • No prior system chemotherapy for advanced/metastatic NSCLC.
  • Measurable diseaseas defined by RECIST v1.1.
  • ECOG performance status of 0 or 1.
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  • Has a life expectancy of at least 3 months.
  • Adequater organ function.
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, and be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug; Male subjects with partners of childbearing potential must either be surgically sterilized or agree to take effective contraceptive measures during the study and within 3 months after the last dose of the study drug.

Who cannot join

  • 1、 Cancer-Specific Exclusions
  • Other histological types of non-small cell lung cancer.
  • Subjects with carcinomatous meningitis and spinal cord compression.
  • Subjects with untreated central nervous system (CNS) metastasis.
  • Subjects who can be treated with surgical resection or radical radiotherapy.
  • Subjects who previously received anti-PD-1(L1) or CTLA4 monoclonal antibody, VEGF or VEGFR signaling pathway single target/multiple target inhibitor or monoclonal antibodies.
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  • 2. Medical history and complications
  • Subjects with any active, known, or suspected autoimmune diseases.
  • Subjects who require systemic corticosteroids prednisone (> 10 mg/day or equivalent) or other immunosuppressants within 14 days prior to the first dose.
  • Subjects who received cancer vaccines or other immunostimulatory anti-cancer agents (interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to the first dose.
  • Subjects who received anti-cancer TCM within 14 days prior to the first dose.
  • Subjects who are in another clinical study or last participated (last dose) in a clinical study less than 4 weeks (or 5 half-lives of the study drug) from the first dose, whichever is shorter.
  • Subjects who are expected to require other forms of anti-cancer treatment during the study.
  • Subjects who received major surgery within 4 weeks prior to the first dose, non-thoracic radiation therapy > 30 Gy within 4 weeks prior to the first dose, thoracic radiation therapy > 30 Gy within 24 weeks prior to the first dose, or palliative radiation ≤ 30 Gy within 2 weeks prior to the first dose, and failed to recover from the toxicities and/or complications of these interventions to NCI-CTC AE Grade ≤ 1 (except for alopecia and fatigue). Palliative radiotherapy for symptomatic control is permitted, but must be completed within 2 weeks prior to starting the study treatment.
  • Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe lung diseases that seriously affect pulmonary function.
  • Subjects with a history of malignant tumors.
  • Subjects with severe cardiovascular disease.
  • Subjectss with hypertension which cannot be well controlled by antihypertensives.
  • Subjects with clinically significant hemorrhage or clear bleeding tendency within 3 month prior to the first dose.
  • Events of arterial/venous thrombosis within 6 months prior to the first dose.
  • Subjects who require long-term anticoagulant therapy with warfarin or heparin.
  • Subjects who require long-term antiplatelet therapy.
  • Significant vascular invasions or a high possibility of significant vascular invasions that may cause bleeding as determined by the investigator during treatment.
  • Subjects with active pulmonary tuberculosis (TB).
  • Subjects with serious infection within 4 weeks prior to the first dose, including but not limited to infective complications, bacteremia, and severe pneumonia that require hospitalization.
  • Subjects who prepare to receive or have previously received tissue/organ transplants.
  • Gastrointestinal disorder or surgical history that may affect the swallowing, digestion, and absorption of the oral drug as determined by the investigator.
  • Subjects who plan to receive or have received live vaccines within 30 days prior to the first dose.
  • Subjects with uncontrolled cancer pain.
  • 3. Physical examination and laboratory tests
  • Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS).
  • Active hepatitis B virus or hepatitis C virus infection.
  • Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • 4. Allergies and adverse drug reactions
  • Severe allergic reactions to other monoclonal antibodies.
  • Allergy or intolerance during an infusion.
  • History of severe allergies to pemetrexed, carboplatin, or their premedications.
  • 5. Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.
  • 6. Based on the investigator's judgment, subjects with a history or current evidence of diseases, treatments, or laboratory abnormalities that may affect study results, interfere with study procedures, or are not in the best interests of the subjects, should be excluded.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Cancer Hosipital

    Beijing, Beijing Municipality, 100089

  • West China Hospital，Sichuan University

    Chengdu, Sichuan, 610000

  • Shanghai Lung Hospital

    Shanghai, Shanghai Municipality, 200433

  • Shengjing Hospita of China Medical University

    Shenyang, Liaoning, 110022

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Hubei Cancer Hospita

    Wuhan, Hubei, 430079

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Phase III Trial of SHR-1210 in Combination With Famitinib or Placebo Plus Chemotherapy in Subjects With Non-squamous Non-small-cell Lung Cancer.

The study is being conducted to evaluate the efficacy and safety of SHR-1210 in combination with Famitinib plus chemotherapy in subjects with NSCLC.

Read the detailed description

The study is being conducted to evaluate the efficacy and safety of Camrelizumab in combination with Famitinib plus chemotherapy in subjects with NSCLC.

Being tested
Camrelizumab;Pemetrexed and Carboplatin; Famitinib;, Camrelizumab;Pemetrexed and Carboplatin;Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab;Pemetrexed and Carboplatin; Famitinib;Drug

    Also called SHR1210

    Part 1:

    Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib

    Part 2:

    Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib

  • Camrelizumab;Pemetrexed and Carboplatin;PlaceboDrug

    Also called SHR1210

    Part 2:

    Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo

Study groups in NCT04619433
Study groupRoleWhat they receive
Treatment group AExperimentalIntervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib
Receives: Drug: Camrelizumab;Pemetrexed and Carboplatin; Famitinib;
Treatment group BPlacebo comparatorIntervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo
Receives: Drug: Camrelizumab;Pemetrexed and Carboplatin;Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1：Serum concentrations of Camrelizumab

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  2. Part 1：Plasma concentrations of Famitinib

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  3. Part 1：Area Under the Plasma Concentration Versus Time Curve (AUC) of Famitinib.

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  4. Part 1：Maximum Concentration (Cmax) of Famitinib.

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  5. Part 1：Time to Maximum Concentration (Tmax) of Famitinib.

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  6. Part 1：Half-life (t1/2 z) of Famitinib.

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  7. Part 1：Apparent Clearance (CL/F) of Famitinib

    Measured: Cycle 2; each cycle is 21 days (up to 42 days）

  8. Part 1：Vz/F of Famitinib.

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  9. Part 2: Progression-free Survival (PFS) as Assessed by BICR according to RECIST 1.1.

    Measured: up to 24 months

Secondary outcomes (10)

  1. Part 1:Objective Response Rate (ORR) as Assessed by investigators

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  2. Part 1:Duration of Response (DOR) as Assessed by investigators

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  3. Part 1:Progression-free Survival (PFS) as Assessed by investigators

    Measured: Cycle 2; each cycle is 21 days (up to 42 days)

  4. Part 1:Overall Survival (OS).

    Measured: Up to approximately 60 months

  5. Part 2:Overall Survival (OS)

    Measured: Up to approximately 60 months

  6. Part 2:Progression-free Survival (PFS) as Assessed by investigators according to RECIST 1.1.

    Measured: up to 24 months

  7. Part 2:Objective Response Rate (ORR) as Assessed by investigators and BICR according to RECIST 1.1

    Measured: up to 24 months

  8. Part 2:Duration of Response (DOR) as Assessed by investigators and BICR according to RECIST 1.1

    Measured: up to 24 months

  9. Part 2:Disease Control Rate(DCR) as Assessed by investigators and BICR according to RECIST 1.1

    Measured: up to 24 months

  10. Part 2:Number of Participants With Adverse Events and Serious Adverse Event as Assessed by CTCAE v5.0.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study start1 Feb 2021
  3. Primary completion16 Aug 2025
  4. Study completion16 Aug 2025

Why it stopped: Terminated by Sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
SHR-1210 in combination with Famitinib plus chemotherapy.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619433
Sponsor's protocol ID
SHR-1210-III-324
Status last verified
Sep 2025
First submitted
5 Nov 2020
Last updated
23 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camrelizumab;Pemetrexed and Carboplatin; Famitinib; in people with Non-squamous Non-small-cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Terminated by Sponsor). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1：Serum concentrations of Camrelizumab (time frame: Cycle 2; each cycle is 21 days (up to 42 days)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04619433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.

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