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Non-Small-Cell Lung Cancer Stage IVPhase 2NCT04238169

Clinical Trial Assessing the Efficacy of Abscopal Effect Induced by SBRT and Immunotherapy in Advanced NSCLC

A Phase 2 study testing Bevacizumab, Toripalimab and SBRT in people with Non-Small-Cell Lung Cancer Stage IV, run by Xinqiao Hospital of Chongqing at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, multicenter, open-label study to observe the effect of SBRT and immunotherapy combined with Bevacizumab or not in stage IV non-squamous non-small cell lung cancer (NSCLC) with previously failed after chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-Small-Cell Lung Cancer Stage IV
What is being tested?
Bevacizumab, Toripalimab and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Sep 2020to 31 Dec 2023
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have signed written informed consent and able to comply with study procedures.
  • Histologically and/or cytologically confirmed advanced metastatic (stage IV) non-squamous non-small cell lung cancer.
  • Previous received first-line platinum-based chemotherapy or immunotherapy (except toripalimab) and followed by progression of disease evaluated by RECIST 1.1.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1.
  • Life expectancy ≥ 12 weeks.
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  • Have at least 3 measurable lesions based on RECIST 1.1, at least 2 of them can be treated by SBRT.
  • Adequate hematologic function as defined by the following laboratory values:
  • Absolute neutrophil count ≥1.5x109/L
  • Platelets ≥80 x 109/L
  • Hemoglobin ≥9 g/dL
  • Adequate Hepatic function: Total bilirubin ≤1.5×ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN OR ≤5×ULN for patients with liver metastases.
  • Adequate renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥50 mL/min and dipstick proteinuria <2+. A 24-hour urine protein test is needed if a dipstick proteinuria result of ≥2+ is detected, the proteinuria level ≤ 1g/24h.
  • International normalized ratio≤1.5 × ULN, prothrombin time (PT) or partial thromboplastin time (PTT or a PTT) ≤1.5 × ULN(within 7 days of assessment).
  • Female who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must be willing to use an adequate method of contraception.
  • Male subjects of childbearing potential must agree to use an adequate method of contraception (failure rate < 1% per year) - Contraception, starting with the first dose of study therapy through 6 months after the last dose of study therapy.

Who cannot join

  • Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g., pulmonary artery or superior vena cava).
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device are excluded within 7 days prior to initiation of study treatment. Placement of a vascular access device should be at least 2 days prior to initiation of study treatment.
  • Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (325 mg/day) or other nonsteroidal anti-inflammatory agents known to inhibit platelet function.
  • Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed.
  • History or evidence of inherited bleeding diathesis or coagulopathy that increases the risk of bleeding.
  • Uncontrolled hypertension (blood pressures: systolic>150 mmHg and/or diastolic >100 mmHg).
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  • Prior history of hypertensive crisis or hypertensive encephalopathy.
  • Clinically significant (i.e., active) cardiovascular disease, including but not limited to cerebral vascular accident (CVA) or (transient ischemic attack) TIA (≤6 months before randomization), myocardial infarction (≤6 months before randomization), unstable angina, congestive heart failure New York Heart Association Class≥II, or serious cardiac arrhythmia requiring medication during the study and that might interfere with regularity of the study treatment or not controlled by medication.
  • Significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization.
  • The lesion has received prior radiotherapy and is not suitable for SBRT.
  • Has stable brain metastases is allowed, but the brain metastases will not receive SBRT or whole brain radiotherapy (WBRT)
  • Malignancies other than NSCLC within 2 years except for basal or squamous cell skin cancer, carcinoma in situ of the cervix and cured early stage prostate cancer.
  • Corticosteroid therapy at a dose equivalent to 10 mg prednisone per day or any other systemic immunosuppressive therapy within 14 days prior to randomization. Topical or inhaled steroids are permitted. Taking immunosuppressive drugs accidentally during the trial will be allowed, but it is strongly recommended to reduce the dose as soon as possible.
  • A positive HIV test result, presence of active HIV, hepatitis B or hepatitis C（evaluate at local laboratories）
  • Non-healing wound, active peptic ulcer, or bone fracture.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.
  • Pregnant or lactating, or intending to become pregnant during the study.
  • Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to randomization.
  • Evidence of ongoing or active infection requiring IV antibiotics; any other disease, neurological, or metabolic dysfunction; physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
  • Patients diagnosed with a tracheo-oesophageal fistula.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xinqiao Hospital of Chongqing

    Chongqing, Chongqing Municipality, 400000

Other trials in China

About this study

This is a prospective, multicenter, open-label study to observe the effect of SBRT and immunotherapy combined with Bevacizumab or not in stage IV non-squamous non-small cell lung cancer (NSCLC) with previously failed after chemotherapy.

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.

  • BevacizumabDrug

    7.5mg/kg once every three weeks

  • ToripalimabDrug

    240 mg once every three weeks

  • SBRTRadiation

    30-50Gy/5F（2-4 lesions）

Study groups in NCT04238169
Study groupRoleWhat they receive
SBRT+ToripalimabExperimentalImmunotherapy：Toripalimab: 240 mg once every three weeks，Until progress of disease or investigators determine that clinical benefit is no longer available or there are intolerable toxicity. SBRT：30-50Gy/5F（2-4 locations).
Receives: Drug: Toripalimab; Radiation: SBRT
SBRT+Bevacizumab+ToripalimabExperimentalImmunotherapy：Toripalimab: 240 mg once every three weeks，Until progress of disease or investigators determine that clinical benefit is no longer available or there are intolerable toxicity. SBRT：30-50 Grays(Gy) in 5 fractions（2-4 locations）. Bevacizumab：7.5mg/kg once every three weeks.
Receives: Drug: Bevacizumab; Drug: Toripalimab; Radiation: SBRT

What is being measured

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

  1. Objective response rate

    Assess the efficacy (overall response rate [ORR]) of SBRT and Toripalimab combined with Bevacizumab or not in stage IV non-squamous NSCLC with previously failed after chemotherapy. (according to RECIST version 1.1 and EORTC 1999)

    Measured: Up to 6 months

  2. Objective response of non-target lesion

    Assess the efficacy (Objective response of non-target lesion) of SBRT and Toripalimab combined with Bevacizumab or not in stage IV non-squamous NSCLC with previously failed after chemotherapy. (according to RECIST version 1.1 and EORTC 1999)

    Measured: Up to 6 months

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    Estimate the progression-free survival (PFS) in patients with NSCLC

    Measured: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy (up to approximately 2 years)

  2. Duration of response

    Duration from the first time reported partial response or complete response to the first time of disease progression or death.

    Measured: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anti-cancer therapy (up to approximately 2 years)

  3. Overall survival

    Duration from the date of initial treatment to the date of death due to any cause.

    Measured: From date of first dose of study drug until withdrawal of consent or death (up to approximately 2 years)

  4. The incidence of adverse events (AEs) as a measure of safety

    An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. Safety and tolerance evaluated by incidence, severity and outcomes of AEs (according to NCI-CTCAE 5.0)

    Measured: For each participant, from the first participant first dose until 30 days after the last dose (up to approximately 2 years)

Timeline

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

  1. First posted23 Jan 2020
  2. Study start1 Sep 2020
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2023

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04238169
Sponsor's protocol ID
XQonc-014
Status last verified
Feb 2024
First submitted
14 Jan 2020
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Toripalimab and SBRT in people with Non-Small-Cell Lung Cancer Stage IV, run by Xinqiao Hospital of Chongqing 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 20 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective response rate (time frame: Up to 6 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?

On the ClinicalTrials.gov record for NCT04238169.

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 28 Feb 2024.

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