Nonsquamous Non-Small Cell Lung CancerPhase 2NCT03830411
A Study of Sintilimab Compared With Docetaxel or Pemetrexed as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy
A Phase 2 study testing Sintilimab, Docetaxel and Pemetrexed in people with Nonsquamous Non-Small Cell Lung Cancer, run by Xin-Hua Xu at 1 site in China.
Trial summary
This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab compared with docetaxel or pemetrexed as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonsquamous Non-Small Cell Lung Cancer
- What is being tested?
- Sintilimab, Docetaxel and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2019to 30 Jun 2022
- 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
- Volunteer to participate in clinical research; fully understand and know the research and sign informed consent;
- Age ≥ 18 years old and ≤ 75 years old, either sex;
- Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;
- Has a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;
- Have at least one measurable lesion as defined by RECIST 1.1;
- Has progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;
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- Patients without activating EGFR mutation;
- Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;
- Normal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );
- Normal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];
- Has a life expectancy of at ≥3 months.
Who cannot join
- ECOG PS >2;
- Small cell lung cancer and squamous NSCLC;
- EGFR mutation or mutation status unknown;
- Known hypersensitivity or allergy to monoclonal antibody;
- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways);
- Active autoimmune disease, or a documented history of autoimmune disease;
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- Treatment with systemic corticosteroids (prednisone≥10mg per day or equivalent dose) or other systemic immunosuppressive medications within 2 weeks prior to the first dose;
- Known history or active human immunodeficiency virus (HIV);
- Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection;
- Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment;
- Active or poorly controlled severe infection;
- Have serious cardiovascular disease: Symptomatic congestive heart failure (New York Heart Association grade III-IV), unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months before randomization;
- Received thoracic radiation therapy of >30 Gy within 6 months prior to first dose of study drug;
- Completed palliative radiotherapy within 7 days prior to first dose of study drug;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Yichang, Hubei, 443003
Xinhua Xu, +8613986747496 ext. +8613986747496, 2732774352@qq.com
About this study
Official title: A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab Compared With Docetaxel or Pemetrexed as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy.
This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab compared with docetaxel or pemetrexed as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
- Conditions
- Nonsquamous Non-Small Cell Lung Cancer
- Being tested
- Sintilimab, Docetaxel, Pemetrexed
- Keywords
- Sintilimab, docetaxel, pemetrexed, nonsquamous non-small-cell lung cancer, wild-type EGFR, second-line treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called IBI308
Sintilimab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
DocetaxelDrug
Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.
PemetrexedDrug
Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Sintilimab | Experimental | Participants will receive Sintilimab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator. Receives: Drug: Sintilimab |
| Arm B: Chemotherapy (Docetaxel or Pemetrexed) | Active comparator | Participants randomized to the chemotherapy arm will receive docetaxel or pemetrexed until disease progression per standard RECIST v1.1 or unacceptable toxicity. Receives: Drug: Docetaxel; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Measured: Approximately 21 months
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria.
Measured: Approximately 21 months
Progression-free survival (PFS)
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
Measured: Approximately 21 months
Duration of response (DOR)
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
Measured: Approximately 21 months
Emergence of adverse events(AEs)
AEs graded using CTCAE (Version 4.0) criteria.
Measured: Approximately 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start13 Mar 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsquamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin-Hua Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin-Hua Xu, China Three Gorges University, Yichang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830411
- Sponsor's protocol ID
- CTGU002
- Status last verified
- Nov 2021
- First submitted
- 2 Feb 2019
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab Compared With Docetaxel or Pemetrexed as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy.
- ClinicalTrials.gov ID
- NCT03830411
- Acronym / sponsor ID
- CTGU002
- Conditions
- Nonsquamous Non-Small Cell Lung Cancer
- Keywords
- Sintilimab, docetaxel, pemetrexed, nonsquamous non-small-cell lung cancer, wild-type EGFR, second-line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Xin-Hua XuUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 5 Feb 2019 (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.
This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab compared with docetaxel or pemetrexed as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Sintilimab | Experimental | Drug: SintilimabParticipants will receive Sintilimab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator. |
| Arm B: Chemotherapy (Docetaxel or Pemetrexed) | Active comparator | Drug: Docetaxel, Drug: PemetrexedParticipants randomized to the chemotherapy arm will receive docetaxel or pemetrexed until disease progression per standard RECIST v1.1 or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Volunteer to participate in clinical research; fully understand and know the research and sign informed consent;
- Age ≥ 18 years old and ≤ 75 years old, either sex;
- Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;
- Has a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;
- Have at least one measurable lesion as defined by RECIST 1.1;
Key exclusion criteria (15 listed)
- ECOG PS >2;
- Small cell lung cancer and squamous NSCLC;
- EGFR mutation or mutation status unknown;
- Known hypersensitivity or allergy to monoclonal antibody;
- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways);
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 |
|---|---|---|
| SintilimabAlso: IBI308Sintilimab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle. | Drug | Arm A: Sintilimab |
| DocetaxelDocetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle. | Drug | Arm B: Chemotherapy (Docetaxel or Pemetrexed) |
| PemetrexedPemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle. | Drug | Arm B: Chemotherapy (Docetaxel or Pemetrexed) |
Primary outcome
Overall Survival (OS)
Time frame: Approximately 21 months
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Approximately 21 months
Progression-free survival (PFS)
Time frame: Approximately 21 months
Duration of response (DOR)
Time frame: Approximately 21 months
Emergence of adverse events(AEs)
Time frame: Approximately 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- 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 Sintilimab, Docetaxel and Pemetrexed in people with Nonsquamous Non-Small Cell Lung Cancer, run by Xin-Hua Xu 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 11 inclusion and 15 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 8 Nov 2021. 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 Xinhua Xu, Master (+8613986747496 ext. +8613986747496, 2732774352@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Approximately 21 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 8 Nov 2021.