Carcinoma, Non-Small-Cell LungPhase 2NCT04956146
Fruquintinib Combined With Sintilimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer
A Phase 2 study testing Fruquintinib，Sintilimab，Pemetrexed，Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous Non-small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Fruquintinib，Sintilimab，Pemetrexed，Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2022to 30 Sep 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary provision of informed consent.
- Males or females aged 18-75.
- Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
- Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, gene mutation)
- At least one lesion can be measured by imaging.
- Have not received systemic treatment in the past.
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- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Life expectancy ≥ 12 weeks.
- Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.
Who cannot join
- Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
- Diagnosed with other malignant diseases other than NSCLC within 5 years.
- Have participated in other interventional clinical research treatments now or within 4 weeks.
- Have previously received multi-targeted kinase inhibitors therapy.
- Have active autoimmune diseases requiring systemic treatment within 2 years.
- Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
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- Clinically uncontrollable pleural effusion/abdominal effusion.
- Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
- Pregnant or breastfeeding females.
- Other serious hazards to the safety of patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Pei Ma, M.D., 008668305931, mapei@jsph.org.cn
About this study
Official title: A Single Arm,Open-label, Study of Fruquintinib Combined With Sintilimab and Chemotherapy in Patients With Unresectable or Metastatic Advanced Wild-type Genotype Non-squamous Non-small Cell Lung Cancer
A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous Non-small Cell Lung Cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Fruquintinib，Sintilimab，Pemetrexed，Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib，Sintilimab，Pemetrexed，CarboplatinDrug
Fruquintinib,fruquintinib at the dose determined in phase safety lead-in,5mg-intermittent (2 weeks on/ 1 week off) ，po，every 3 weeks(q3w) ; Sintilimab at the dose 200mg，iv, d1, given every 3 weeks (q3w); Pemetrexed at the dose 500 mg/m2，iv，d1，given every 3 weeks (q3w); Carboplatin at the dose AUC=4~5，iv，d1；given every 3 weeks (q3w); Maintenance treatment：After 4~6 cycles of carboplatin treatment, Sintilimab 200mg, iv, d1, q3w；Fruquintinib RP2D intermittent(2 weeks on/1 weeks off), po，q3w； pemetrexed 500mg/m2, d1,iv, q3w until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib Combined With Sintilimab and Chemotherapy | Experimental | Not described Receives: Drug: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-
Measured: up to 24 months
Secondary outcomes (3)
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Measured: up to 24 months
Disease control rate (DCR)
CR + PR + SD rate according to the RECIST
Measured: up to 24 months
Overall Survival（OS）
Overall survival is determined from the date of treatment to death from any cause or the last follow-up date
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.
- First posted9 Jul 2021
- Study start2 Feb 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956146
- Sponsor's protocol ID
- HMPL-013-FLAG-L101
- Status last verified
- Feb 2022
- First submitted
- 30 Jun 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm,Open-label, Study of Fruquintinib Combined With Sintilimab and Chemotherapy in Patients With Unresectable or Metastatic Advanced Wild-type Genotype Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04956146
- Acronym / sponsor ID
- HMPL-013-FLAG-L101
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous Non-small Cell Lung Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib Combined With Sintilimab and Chemotherapy | Experimental | Drug: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary provision of informed consent.
- Males or females aged 18-75.
- Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
- Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, gene mutation)
- At least one lesion can be measured by imaging.
Key exclusion criteria (10 listed)
- Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
- Diagnosed with other malignant diseases other than NSCLC within 5 years.
- Have participated in other interventional clinical research treatments now or within 4 weeks.
- Have previously received multi-targeted kinase inhibitors therapy.
- Have active autoimmune diseases requiring systemic treatment within 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruquintinib，Sintilimab，Pemetrexed，CarboplatinFruquintinib,fruquintinib at the dose determined in phase safety lead-in,5mg-intermittent (2 weeks on/ 1 week off) ，po，every 3 weeks(q3w) ; Sintilimab at the dose 200mg，iv, d1, given every 3 weeks (q3w); Pemetrexed at the dose 500 mg/m2，iv，d1，given every 3 weeks (q3w); Carboplatin at the dose AUC=4~5，iv，d1；given every 3 weeks (q3w); Maintenance treatment：After 4~6 cycles of carboplatin treatment, Sintilimab 200mg, iv, d1, q3w；Fruquintinib RP2D intermittent(2 weeks on/1 weeks off), po，q3w； pemetrexed 500mg/m2, d1,iv, q3w until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal | Drug | Fruquintinib Combined With Sintilimab and Chemotherapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: up to 24 months
To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-
3 secondary outcomes
Objective response rate (ORR)
Time frame: up to 24 months
Disease control rate (DCR)
Time frame: up to 24 months
Overall Survival（OS）
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib，Sintilimab，Pemetrexed，Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 10 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongqian Shu, PhD (00862568306428, shuyongqian@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2022.