PFSPhase 2NCT05267366
Chemotherapy Combines With Bevacizumab and PD-1 Inhibitor in Non-squamous NSCLC
A Phase 2 study testing PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, Pemtrexed in people with PFS and OS, run by Qingdao Central Hospital at 1 site in China.
Trial summary
In recent years, immunotherapy has emerged as a form of treatment that can lead to robust responses in a subset of patients. PD-1 inhibitor plus chemotherapy showed prolonged survival in NSCLC by the study of KEYNOTE 024, KEYNOTE 189 etc. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, Pemtrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Must have histologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer
- Must have not harbor an EGFR mutation in exon 19 or exon 21, or without an ALK or ROS1 rearrangement,.
- Must have measurable disease by CT or MRI, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v 1.1
- Age > 18 years
- ECOG performance status of 0 or 1, or 2.
- Must have normal organ and marrow function as defined below. The use of G-CSF should follow standard recommendations and physician discretion. If blood transfusion is performed for achieving hemoglobin levels, the levels should stay at ≥ 9.0 mg/ml for at least a week after transfusion.
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- Absolute neutrophil count > 1,500/mcL Hemoglobin ≥ 9.0 mg/ml Platelets > 100,000/mcL Total bilirubin ≤1.5 X institutional upper limit of normal (ULN) AST/ALT (SGOT/SGPT) < 3 times institutional normal limits, or up to 5 times institutional normal limits if the patient has liver metastases Creatinine OR Creatinine clearance ≤1.5 X ULN, OR > 40 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal as per Cockcroft-Gault formula International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) <1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Thyroid stimulating hormone (TSH) Within normal limits a
- a: If TSH is not within normal limits at baseline, the subject will still be eligible if total T3 or free T4 are within normal limits.
- Full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR ≤3.0. For heparin and LMWH there should be no clinically significant active bleeding (with no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices).
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
- A biopsy, either core, cell block from FNA or cell block from surgical resection, must be available for the study. If the sample is not adequate, the patient must agree to provide a fresh biopsy specimen before the start of treatment. Any available archival tissue will also be collected. While a biopsy sample must be adequate and available for the study, an inadequate tissue sample would not be explicitly exclusionary and further discussion with the sponsor is allowed to assess the eligibility of the patient for the trial if, for clinical or other reasons, a new biopsy sample cannot be obtained.
- Urinary protein must be ≤1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥2+, a 24 hour urine collection for protein must demonstrate <1000 mg of protein in 24 hours to allow participation in the protocol).
Who cannot join
- . Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints.
- Received prior platinum-based chemotherapy for advanced disease.
- Patients who have received prior systemic anti-vascular therapy (e.g., bevacizumab and small molecule VEGFR inhibitors) for advanced disease (Cohort 2)
- Treatment with any approved systemic anti-cancer therapy or systemic immune-stimulatory agents (including but not limited to interferons, interleukin IL-, and tumor necrosis factor) within 28 days prior to initiation of study treatment.
- Clinically uncontrolled pleural effusion or ascites that requires pleurocentesis or abdominal tapping for drainage within 2 weeks prior to initiation of study treatment.
- Active leptomeningeal disease or uncontrolled brain metastasis.
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- History of allergic reactions to any study drugs.
- CrCl < 45 mL/min
- Patients with active viral hepatitis that requires treatment.
- Active autoimmune diseases that requires treatment and may affect study treatment estimated by investigator.
- Any condition that required systemic treatment with either corticosteroids or any other immunosuppressive medication that may affect study treatment estimated by investigator.
- Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy.
- History of hemoptysis, i.e., coughing up at least one-half teaspoon of fresh blood, within 3 months prior to enrollment. (Cohort 2)
- Imaging shows tumor invasion of a large vessel (e.g., pulmonary artery or superior vena cava) that the investigator determines is at risk for bleeding. (Cohort 2)
- Had minor surgical procedures, such as tube placement, within 48 hours prior to first bevacizumab treatment. (Cohort 2)
- Recently treated with a full dose oral or parenteral anticoagulant or thrombolytic agent. Prophylactic using anticoagulants is allowed. (Cohort 2)
- History or test results indicating an inherited bleeding tendency or coagulation disorder that may increase the risk of bleeding (cohort 2)
- uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) (cohort 2)
- Clinically meaningful (e.g., active) cardiovascular disease that, in the judgment of the investigator, is intolerant to bevacizumab therapy (cohort 2)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qingdao central Hospital
Qingdao, Shandong, 266042
Youxin Ji, MD, 68665078, ji6677@gmail.com
About this study
Official title: Phase II Randomized Trial of Carboplatin/Cisplatin+Pemetrexed+PD-1 Inhibitor+/- Bevacizumab in Stage IV Non-squamous NSCLC
In recent years, immunotherapy has emerged as a form of treatment that can lead to robust responses in a subset of patients. PD-1 inhibitor plus chemotherapy showed prolonged survival in NSCLC by the study of KEYNOTE 024, KEYNOTE 189 etc. Thus, this study combines immunotherapeutic agent PD-1 inhibitor with an ant-angiogenic agent, bevacizumab, and double platinum therapy (carboplatin/cisplatin and pemetrexed).
- Being tested
- PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, Pemtrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, PemtrexedDrug
PD-1 inhibitor (pembrolizumab) 200mg iv, d1; bevzcizumab 15mg/kg, iv, d1; Carboplatin 5/AUC or Cisplatin 75mg/m2 iv d1; Pemtrexed 500mg/m2 iv, d1; every 21 days a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Chemothreapy with PD-1 inhibitor and bevacizumab | Experimental | PD-1 inhibitor (pembrolizumab) 200mg iv day 1 Carboplatin 5 AUC /cisplatin 75 mg/m2, iv day 1 Pemtrexed 500 mg/m2, iv day 1 Bevacizumab 15 mg/m2, iv day 1 as induction therapy every 21 days a cycle for 4 cycles, PD-1 inhibitor (pembrolizumab) 200mg iv day 1 Bevacizumab 15mg/m2, iv day 1 every 21 days a cycles as maintenance treatment for 31 cycles or 2 years. Receives: Drug: PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, Pemtrexed |
| Chemothreapy with PD-1 inhibitor | Active comparator | PD-1 inhibitor (pembrolizumab) 200mg iv day 1 Carboplatin 5 AUC /cisplatin 75 mg/m2, iv day 1 Pemtrexed 500 mg/m2, iv day 1 as induction therapy every 21 days a cycle for 4 cycles, PD-1 inhibitor (pembrolizumab) 200mg iv day 1 every 21 days a cycles as maintenance treatment for 31 cycles or 2 years. Receives: Drug: PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, Pemtrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival (per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first.
Measured: up to 24 months
Overall Survival (OS)
OS is defined as the time from the starting date of study drug to the date of death due to any cause.
Measured: up to 24 months
Secondary outcomes (2)
Objective Respond Rate (ORR)
ORR (per RECIST 1.1) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).
Measured: up to 24 months
Duration of Response (DoR)
DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
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 posted4 Mar 2022
- Study start1 Feb 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFSStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267366
- Sponsor's protocol ID
- QDCH2022-02-15
- Status last verified
- Mar 2023
- First submitted
- 14 Feb 2022
- Last updated
- 29 Mar 2023
- 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial of Carboplatin/Cisplatin+Pemetrexed+PD-1 Inhibitor+/- Bevacizumab in Stage IV Non-squamous NSCLC
- ClinicalTrials.gov ID
- NCT05267366
- Acronym / sponsor ID
- QDCH2022-02-15
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 4 Mar 2022 (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.
In recent years, immunotherapy has emerged as a form of treatment that can lead to robust responses in a subset of patients. PD-1 inhibitor plus chemotherapy showed prolonged survival in NSCLC by the study of KEYNOTE 024, KEYNOTE 189 etc. Thus, this study combines immunotherapeutic agent PD-1 inhibitor with an ant-angiogenic agent, bevacizumab, and double platinum therapy (carboplatin/cisplatin and pemetrexed).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemothreapy with PD-1 inhibitor and bevacizumab | Experimental | Drug: PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, PemtrexedPD-1 inhibitor (pembrolizumab) 200mg iv day 1 Carboplatin 5 AUC /cisplatin 75 mg/m2, iv day 1 Pemtrexed 500 mg/m2, iv day 1 Bevacizumab 15 mg/m2, iv day 1 as induction therapy every 21 days a cycle for 4 cycles, PD-1 inhibitor (pembrolizumab) 200mg iv day 1 Bevacizumab 15mg/m2, iv day 1 every 21 days a cycles as maintenance treatment for 31 cycles or 2 years. |
| Chemothreapy with PD-1 inhibitor | Active comparator | Drug: PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, PemtrexedPD-1 inhibitor (pembrolizumab) 200mg iv day 1 Carboplatin 5 AUC /cisplatin 75 mg/m2, iv day 1 Pemtrexed 500 mg/m2, iv day 1 as induction therapy every 21 days a cycle for 4 cycles, PD-1 inhibitor (pembrolizumab) 200mg iv day 1 every 21 days a cycles as maintenance treatment for 31 cycles or 2 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- • Must have histologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer
- Absolute neutrophil count > 1,500/mcL Hemoglobin ≥ 9.0 mg/ml Platelets > 100,000/mcL Total bilirubin ≤1.5 X institutional upper limit of normal (ULN) AST/ALT (SGOT/SGPT) < 3 times institutional normal limits, or up to 5 times institutional normal limits if the patient has liver metastases Creatinine OR Creatinine clearance ≤1.5 X ULN, OR > 40 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal as per Cockcroft-Gault formula International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) <1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Thyroid stimulating hormone (TSH) Within normal limits a
- a: If TSH is not within normal limits at baseline, the subject will still be eligible if total T3 or free T4 are within normal limits.
- Full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR ≤3.0. For heparin and LMWH there should be no clinically significant active bleeding (with no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices).
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
Key exclusion criteria (19 listed)
- . Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints.
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 |
|---|---|---|
| PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, PemtrexedPD-1 inhibitor (pembrolizumab) 200mg iv, d1; bevzcizumab 15mg/kg, iv, d1; Carboplatin 5/AUC or Cisplatin 75mg/m2 iv d1; Pemtrexed 500mg/m2 iv, d1; every 21 days a cycle. | Drug | Chemothreapy with PD-1 inhibitor, Chemothreapy with PD-1 inhibitor and bevacizumab |
Primary outcome
Progression-free survival
Time frame: up to 24 months
Progression-free survival (per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first.
Overall Survival (OS)
Time frame: up to 24 months
OS is defined as the time from the starting date of study drug to the date of death due to any cause.
2 secondary outcomes
Objective Respond Rate (ORR)
Time frame: up to 24 months
Duration of Response (DoR)
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 29 Mar 2023.
- 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 PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, Pemtrexed in people with PFS and OS, run by Qingdao Central Hospital 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 12 inclusion and 19 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 29 Mar 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: up to 24 months). 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 29 Mar 2023.