Lung NeoplasmsPhase 2NCT04513301
Efficacy and Safety of Sintilimab With or Without Radiotherapy in Patients With Recurrent or IV NSCLC (EGFR -, ALK -) After Failure of Platinum-based Chemotherapy: A Randomized,Open Labled, Phase II Clinical Study
A Phase 2 study testing Sintilimab and Radiotherapy in people with Lung Neoplasms, run by Shanghai Cancer Hospital, China at 1 site in China.
Trial summary
Lung cancer incidence and mortality have been increasing steeply in the past thirty years in the mainland of China. More than 80% of lung cancer is non-small cell lung cancer (NSCLC). More than 40% of NSCLC patients are found to be in stage IIIb or IV, which is not resectable. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Sintilimab and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Dec 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
- Signed written informed consent prior to the implementation of any test-related process.
- Age ≥ 18 and ≤ 75.
- Life expectancy exceeding 3 months.
- Non-small cell lung cancer is confirmed histologically or cytologically (either as an initial diagnosis or a subsequent biopsy). However, the Sputum cytology results alone are unacceptable. Cytology results of tracheal brush test, tracheal flush fluid and needle aspiration puncture is acceptable.
- The investigator confirms the presence of at least one measurable lesion according to the RECIST 1.1 criteria.
- Patients with stage IV, or recurrent NSCLC with histologically or cytologically confirmed , according to the International Association for the Study of Lung Cancer and the Joint Committee on American Cancer Classification, 8th edition, TNM stage of lung cancer.
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- Patients confirmed by histological specimens not applicable to EGFR or ALK-targeted therapy (with documented evidence of no tumor EGFR sensitivity mutations and no ALK gene rearrangements).
- Eastern Oncology Collaborative Group (ECOG) fitness status score of 0 or 1.
- Have received at least one regimen of platinum-containing chemotherapy with tumor progression or inability to tolerate chemotherapy response in the most recent chemotherapy regimen.
- Good hematopoiesis, defined as an absolute neutrophil count ≥1.5 × 109/L, platelet count≥100 × 109/L, blood Erythropoietin ≥ 90 g/L
- Good liver function, defined as total bilirubin levels ≤ 1.5 times the upper limit of normal(ULN); in patients without hepatic metastases, glutinous rice cereal is used as a supplement.
- Aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; for patients with documented liver metastases, AST and ALT levels ≤ 5 times ULN.
- Good renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); urine protein less than 2+ on routine urinalysis, or 24-hour urine protein quantification < 1 g.
- Good coagulation, defined as an International Standardised Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulant therapy, provided that the PT is within the intended use range of the anticoagulant.
- For female subjects of childbearing age, a negative urine or serum pregnancy test should be presented within 3 days prior to receiving the first study drug administration (Week 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test will be requested.
- If there is a risk of conception, both male and female patients need to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) and continue until at least 180 days after discontinuation of the trial treatment.
Who cannot join
- Currently participating in an interventional clinical research treatment, or has received another investigational drug or used an investigational device within 4 weeks prior to the first administration of the drug.
- Previously received an anti-PD-1, anti-PD-L1, or anti-PD-L2 drug or a drug that stimulates or synergistically inhibits another T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- Systemic systemic therapy with an anti-lung cancer indication with a proprietary Chinese medicine or immunomodulatory drug (including thymidine, interferon, interleukin, except for local use for pleural control) within 2 weeks prior to the first dose, or major surgery within 3 weeks prior to the first dose.
- Previous experience of chest radiotherapy.
- Palliative radiotherapy completed within 7 days prior to the first administration of the drug.
- Presence of clinically active diverticulitis, abdominal abscesses, gastrointestinal obstruction.
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- Have received a transplant of a solid organ or blood system.
- Presence of clinically uncontrollable pleural effusion/abdominal fluid.
- Known severe allergic reaction (grade ≥3) to cedirizumab, or other immunotherapeutic agents.
- Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants) occurring within 2 years prior to the first dose of the drug. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic therapy.
- Diagnosis of immunodeficiency or being on systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first administration of the study; physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted.
- Have not sufficiently recovered from toxicity and/or complications from any of the interventions prior to initiating treatment (i.e. ≤ grade 1 or at baseline, not including weakness or hair loss).
- Diagnosis of other malignancies within 5 years prior to the first dose, with exceptions including radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ.
- Symptomatic central nerve metastases. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastatic lesions may be enrolled in this study if all of the following criteria are met: measurable lesions outside the central nervous system; absence of midbrain, bridge, cerebellum, medulla oblongata or spinal cord metastases; maintenance of clinical stability for at least 2 weeks; and cessation of hormonal therapy 3 days prior to the first dose of study drug.
- A history of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to the first administration of the drug.
- Active infections that require systemic treatment.
- (a) The known existence of a mental illness or substance abuse condition that may affect compliance with the test requirements.
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
- Note: Subjects with hepatitis B who meet the following criteria are also eligible for enrollment: HBV viral load must be <1000 copies/ml (200 IU/ml) prior to first dose and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of study chemotherapy drug therapy. Subjects with anti-HBc (+), HBsAg (-), anti-HB (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV therapy but need to be monitored closely for viral reactivation.
- Active HCV-infected subjects (HCV antibody-positive and HCV-RNA levels above the lower limit of detection).
- Live vaccine within 30 days prior to first dose (Cycle 1, Day 1); NOTE: Injectable inactivated viral vaccine against seasonal influenza is allowed up to 30 days prior to first dose; however, live attenuated influenza vaccine for intranasal administration is not allowed.
- Evidence of a medical history or illness that could interfere with the results of the trial, prevent the subject from participating throughout the study, abnormal values for treatment or laboratory tests, or other circumstances that, in the opinion of the investigator, make enrollment unsuitable.
- Breastfeeding women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University shanghai cancer center
Shanghai, Shanghai Municipality, 200000
min Fan, master, 18017312298, fanming@fudan.edu.cn
About this study
Official title: Efficacy and Safety of Sintilimab With or Without Radiotherapy in Chinse Patients With Recurrent or IV NSCLC (EGFR -, ALK -) After Failure of Platinum-based Chemotherapy: A Randomized, Controlled, Phase II Clinical Study
Lung cancer incidence and mortality have been increasing steeply in the past thirty years in the mainland of China. More than 80% of lung cancer is non-small cell lung cancer (NSCLC). More than 40% of NSCLC patients are found to be in stage IIIb or IV, which is not resectable. The 5-year survival rate for this group of patients is less than 5% in the SEER database. Currently, the NCCN guidelines recommend platinum-containing double-drug chemotherapy as the first- line standard of care for advanced NSCLC without driver gene mutations, and treatment options after failure of first-line chemotherapy are limited. Immune Checkpoint Inhibitors, ICIs provide new treatment options, and in addition, radiotherapy can also be used in selected patients with advanced NSCLC, especially in patients with oligo progression, where irradiation of the thoracic primary lesions can improve the patient's respiratory-related symptoms, reduce the tumor burden, improve the patient's quality of life, and prolong survival in some patients. Therefore, we propose that combination of immunotherapy and radiotherapy to the primary lesion for these patients, who are generally in good KPS status, may result in improved quality of life and prolonged survival. To date, there have been no clinical studies of immunotherapy combined with primary lesions radiation therapy in patients with advanced non-small cell lung cancer (driver gene-negative) after chemotherapy failure or recurrence, so we designed this prospective, randomized, controlled, investigator-initiated, phase II clinical study with the primary objective of evaluating the efficacy of combined immunotherapy and primary lesions radiation therapy in this patient population. This trial aims at investigating the feasibility and efficacy of this treatment strategy.
- Conditions
- Lung Neoplasms
- Being tested
- Sintilimab, Radiotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab (200 mg q3w ×2 cycle)
RadiotherapyRadiation
RT 50-60Gy/25-30f
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab alone | Active comparator | Sintilimab (200 mg q3w ×2cycle) Receives: Drug: Sintilimab |
| Sintilimab+Radiotherapy | Experimental | Sintilimab (200 mg q3w ×2cycle)+RT 50-60Gy/25-30f Receives: Drug: Sintilimab; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective reactive rate
12-week objective reactive rate (ORR)
Measured: 12-week
adverse events
grade 3-5 adverse events acording CTCAE 5.0
Measured: three year
Secondary outcomes (1)
progression-free survival (PFS) in two groups
Progression-Free Survival PFS is defined as the time from randomization to progression or death. (Time to progression is a related, less-preferred end point wherein deaths without progression are censored observations rather than counted as events.)
Measured: three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Jan 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Cancer Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Fan, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513301
- Sponsor's protocol ID
- IBI308 ZL001
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sintilimab With or Without Radiotherapy in Chinse Patients With Recurrent or IV NSCLC (EGFR -, ALK -) After Failure of Platinum-based Chemotherapy: A Randomized, Controlled, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT04513301
- Acronym / sponsor ID
- IBI308 ZL001
- Conditions
- Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Cancer Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 14 Aug 2020 (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.
Lung cancer incidence and mortality have been increasing steeply in the past thirty years in the mainland of China. More than 80% of lung cancer is non-small cell lung cancer (NSCLC). More than 40% of NSCLC patients are found to be in stage IIIb or IV, which is not resectable. The 5-year survival rate for this group of patients is less than 5% in the SEER database. Currently, the NCCN guidelines recommend platinum-containing double-drug chemotherapy as the first- line standard of care for advanced NSCLC without driver gene mutations, and treatment options after failure of first-line chemotherapy are limited. Immune Checkpoint Inhibitors, ICIs provide new treatment options, and in addition, radiotherapy can also be used in selected patients with advanced NSCLC, especially in patients with oligo progression, where irradiation of the thoracic primary lesions can improve the patient's respiratory-related symptoms, reduce the tumor burden, improve the patient's quality of life, and prolong survival in some patients. Therefore, we propose that combination of immunotherapy and radiotherapy to the primary lesion for these patients, who are generally in good KPS status, may result in improved quality of life and prolonged survival. To date, there have been no clinical studies of immunotherapy combined with primary lesions radiation therapy in patients with advanced non-small cell lung cancer (driver gene-negative) after chemotherapy failure or recurrence, so we designed this prospective, randomized, controlled, investigator-initiated, phase II clinical study with the primary objective of evaluating the efficacy of combined immunotherapy and primary lesions radiation therapy in this patient population. This trial aims at investigating the feasibility and efficacy of this treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab alone | Active comparator | Drug: SintilimabSintilimab (200 mg q3w ×2cycle) |
| Sintilimab+Radiotherapy | Experimental | Drug: Sintilimab, Radiation: RadiotherapySintilimab (200 mg q3w ×2cycle)+RT 50-60Gy/25-30f |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed written informed consent prior to the implementation of any test-related process.
- Age ≥ 18 and ≤ 75.
- Life expectancy exceeding 3 months.
- Non-small cell lung cancer is confirmed histologically or cytologically (either as an initial diagnosis or a subsequent biopsy). However, the Sputum cytology results alone are unacceptable. Cytology results of tracheal brush test, tracheal flush fluid and needle aspiration puncture is acceptable.
- The investigator confirms the presence of at least one measurable lesion according to the RECIST 1.1 criteria.
Key exclusion criteria (23 listed)
- Currently participating in an interventional clinical research treatment, or has received another investigational drug or used an investigational device within 4 weeks prior to the first administration of the drug.
- Previously received an anti-PD-1, anti-PD-L1, or anti-PD-L2 drug or a drug that stimulates or synergistically inhibits another T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- Systemic systemic therapy with an anti-lung cancer indication with a proprietary Chinese medicine or immunomodulatory drug (including thymidine, interferon, interleukin, except for local use for pleural control) within 2 weeks prior to the first dose, or major surgery within 3 weeks prior to the first dose.
- Previous experience of chest radiotherapy.
- Palliative radiotherapy completed within 7 days prior to the first administration of the drug.
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 |
|---|---|---|
| SintilimabSintilimab (200 mg q3w ×2 cycle) | Drug | Sintilimab alone, Sintilimab+Radiotherapy |
| RadiotherapyRT 50-60Gy/25-30f | Radiation | Sintilimab+Radiotherapy |
Primary outcome
objective reactive rate
Time frame: 12-week
12-week objective reactive rate (ORR)
adverse events
Time frame: three year
grade 3-5 adverse events acording CTCAE 5.0
1 secondary outcome
progression-free survival (PFS) in two groups
Time frame: three year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Min Fan study director
Fudan University
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 and Radiotherapy in people with Lung Neoplasms, run by Shanghai Cancer Hospital, China 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 16 inclusion and 23 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 14 Aug 2020. 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 Jiayan Chen, Master (86-18121299483, chenjiayan2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective reactive rate (time frame: 12-week). The study lists 2 primary outcomes in all. 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 14 Aug 2020.