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Recurrent Small Cell Lung CancerPhase 2NCT05162196

The Efficacy and Safety of Radiotherapy Plus Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung Cancer

A Phase 2 study testing SBRT, Toripalimab and Niraparib in people with Recurrent Small Cell Lung Cancer, run by Wuhan University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, multicenter, open-label study to observe the efficacy and safety of combination with radiotherapy, niraparib and toripalimab in patients With recurrent small cell lung cancer(SCLC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Recurrent Small Cell Lung Cancer
What is being tested?
SBRT, Toripalimab and Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
No sites listed yet
Study dates
Jun 2022to Dec 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

  • Histologically or cytologically confirmed small cell lung cancer.
  • Age ≥ 18 years.
  • Previously received 1-2 lines of treatment (including 1 systemic platinum-containing treatment), and responded to the first platinum-containing treatment (response is defined as CR, PR or SD).
  • At least 1 measurable target lesion based on RECIST 1.1.
  • Allow previous anti-PD-L1 antibody treatment, enrolled patients ≤ 30% of the total enrolled number.
  • Life expectancy ≥ 12 weeks.
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2.
  • Adequate hematologic function, hepatic function and renal function
  • 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.
  • . Toxic side effect to any previous chemotherapy has returned to ≤ CTCAE Grade 1 or baseline, or except sensory neuropathy or hair loss with stable symptoms ≤ CTCAE Grade 2.

Who cannot join

  • People who are known to be allergic to Niraparib or to active or inactive ingredients of drugs with similar chemical structure to Niraparib.
  • People who are known to be allergic to Toripalimab or to active or inactive ingredients of drugs with similar chemical structure to Toripalimab.
  • Symptomatic and uncontrolled cerebral or leptomeningeal metastasis. No imaging scan is required to confirm no brain metastases; subjects with spinal cord compression may be considered for inclusion if they have received targeted treatment and evidence of clinical stability of the disease for at least 28 days (patients with controlled CNS metastases must have received treatment such as radiotherapy or chemotherapy at least one month before entering the study; subjects should not develop new symptoms related to central nervous system lesions or symptoms indicating disease progression, and subjects either take stable doses of hormones or do not need to take hormones).
  • Chemotherapy or major surgery was performed within 3 weeks prior to the study or any surgical effect that has not been recovered after surgery.
  • Radiotherapy for target lesions within 4 weeks of initiating study drugs, or palliative radiotherapy for >20% bone marrow within 1 week prior to enrollment.
  • Patients with high risk of massive hemoptysis (such as uncured bronchiectasis, pulmonary tuberculosis).
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  • Malignancies other than small cell lung cancer within 5 years prior to enrollment (except for radically treated cervical cancer in situ, basal cell carcinoma and superficial bladder tumor).
  • Patients with previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Severe or uncontrolled conditions or diseases, including but not limited to:
  • Uncontrollable nausea and vomiting, inability to swallow study drugs, or any gastrointestinal disease that could affect drug absorption or metabolism.
  • Active virus infections such as human immunodeficiency virus (HIV) (positive HIV antibody), hepatitis B virus (HBV; positive HBsAg-positive status and HBV-DNA ≥10^3 copy number/mL or ≥500 IU/mL), and hepatitis C virus (HCV; positive anti-HCV antibody and/or positive HCV RNA in combination with clinical judgment).
  • Uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or mental disease impairing the participant's ability to give informed consent.
  • Known diagnosis of immunodeficiency (except for splenectomy) or other conditions that might predispose participants to a high risk of toxicity, as judged by the investigator.
  • Need to use any type of corticosteroids for systemic treatment within 14 days of study medication (>10mg/day prednisone) or other immunosuppressive drugs; in the absence of active autoimmune diseases, inhaled or topical steroids and Adrenal replacement dose (≤10mg/day prednisone); Allow patients to use topical, intraocular, intra-articular, intranasal and inhaled corticosteroids (small systemic absorption); allow physiological alternative doses of systemic corticosteroids (≤10mg/day prednisone); for prevention (such as contrast agents) Allergy) or short-term corticosteroid therapy for non-autoimmune diseases (such as delayed hypersensitivity caused by contact allergens) is allowed.
  • History of bleeding tendency and thrombosis:
  • Any bleeding events with CTCAE level 2 occurred within 3 months before screening, or with CTCAE level 3 and above within 6 months before screening
  • A history of gastrointestinal hemorrhage or a clear tendency of gastrointestinal hemorrhage within 6 months before screening. For example: esophageal varices with bleeding risk, local active ulcer lesions, or fecal occult blood + + or above
  • With active bleeding or coagulation abnormalities, bleeding tendency, or receiving thrombolytic or anticoagulation therapy
  • Subjects need anticoagulant therapy with warfarin or heparin
  • Subjects will require long-term antiplatelet therapy (e.g., aspirin, clopidogrel)
  • Thrombotic or embolic event within the past 6 months, e.g., cerebrovascular accident (including transient ischemic attack), and pulmonary embolism.
  • Serious cardiovascular history:
  • NYHA (New York Heart Association) grade 3 and 4 congestive heart failure
  • Unstable angina or newly diagnosed angina or myocardial infarction within 12 months before screening
  • Arrhythmias requiring therapeutic intervention (subjects taking β-blockers or digoxin may be enrolled)
  • ≥ CTCAE Grade 2 valvular heart disease
  • Poorly controlled hypertension (SBP > 150 mmHg or DBP > 100 mmHg).
  • Other laboratory abnormalities:
  • Hyponatremia (sodium <130 mmol/L); baseline serum potassium <3.5 mmol/L (potassium supplements can be used to restore serum potassium to above level before entering the study).
  • Abnormal thyroid function which cannot be maintained within the normal range with drugs.
  • Any previous or current disease, treatment or laboratory abnormality that may interfere with the results of the study, affect the subject's participation in the whole process of the research, or the researcher believes that the subject is not suitable for participating in this research; the subjects should not receive platelet or red cell transfusion within 4 weeks prior to the start of treatment with the study drug.
  • Subjects who are pregnant or breast-feeding or expect to become pregnant during the study treatment period.
  • Corrected QT interval (QTc)>450 milliseconds; if the subject has a prolonged QTc interval, but the investigator evaluates that the cause of the prolongation is a cardiac pacemaker (without other cardiac abnormalities), it is necessary to discuss with the investigator to determine whether the subject is suitable for inclusion in the study.
  • Previous treatment with any PARP inhibitors.
  • Previous treatment with any anti-PD-1 inhibitors.
  • Subjects are participating in other clinical studies or it is less than 1 month from the end of the previous clinical study.

Trial locations and contacts

No sites are listed yet.

Conghua Xie, MD,PhD contact

0086-27-67812607

chxie_65@hotmail.com

About this study

Official title: Radiotherapy Combined With Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung Cancer (CREATE): A Open-label, Single-arm, Phase II Study

This is a prospective, multicenter, open-label study to observe the efficacy and safety of combination with radiotherapy, niraparib and toripalimab in patients With recurrent small cell lung cancer(SCLC).

Being tested
SBRT, Toripalimab, Niraparib
Keywords
Radiotherapy, Toripalimab, Niraparib
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05162196
Study groupRoleWhat they receive
SBRT combined with Niraparib and ToripalimabExperimentalInduction therapy (cyc1: D1-D28): Niraparib 200mg QD + SBRT 8Gy✖️3 QD, D4-D6 + Toripalimab 240mg iv drip D7 Maintenance (cyc2+): Niraparib 200mg QD, D1-D21 + Toripalimab 240mg iv drip D1, until disease progression or intolerable toxicity
Receives: Radiation: SBRT; Drug: Toripalimab; Drug: Niraparib

What is being measured

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

  1. ORR (Objective response rate)

    Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1

    Measured: Approximately 2 years

Secondary outcomes (8)

  1. DOR (Duration of Response)

    Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1

    Measured: Approximately 2 years

  2. DCR (Disease of Response)

    Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1

    Measured: Approximately 2 years

  3. PFS (Progression Free Survival)

    Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)

    Measured: Approximately 2 years

  4. PFS (Progression Free Survival) Rate

    PFS rates at 6-month（inestigators and BICR） and at 1-year

    Measured: Approximately 1year

  5. Overall suvival (OS)

    Overall suvival (OS)

    Measured: Approximately 2 years

  6. OS (Overall Survival) rate

    OS rates at 1 years

    Measured: Approximately 1 years

  7. Intrathoracic and extrathoracic recurrence rate

    Measured: Approximately 2 years

  8. 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: 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 posted17 Dec 2021
  2. Study startJun 2022 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05162196
Sponsor's protocol ID
CREATE
Status last verified
Apr 2022
First submitted
4 Dec 2021
Last updated
2 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT, Toripalimab and Niraparib in people with Recurrent Small Cell Lung Cancer, run by Wuhan University.

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 36 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 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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 Conghua Xie, MD,PhD (0086-27-67812607, chxie_65@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (Objective response rate) (time frame: Approximately 2 years). 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 NCT05162196.

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 May 2022.

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