NSCLC Stage IVPhase 2NCT05055583

Toripalimab in Combination With Platinum-based Chemotherapy for Mutation-negative Stage IV Oligometastatic NSCLC

A Phase 2 study testing Toripalimab in Combination With Platinum-based Chemotherapy, Surgical treatment stage and Adjuvant treatment stage in people with NSCLC Stage IV and Oligometastasis, run by Tang-Du Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: NSCLC Stage IV, Oligometastasis
What is being tested?: Toripalimab in Combination With Platinum-based Chemotherapy, Surgical treatment stage and Adjuvant treatment stage
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 31 Aug 2021to 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

Age: 18 ~ 70 years old, male or female.
ECOG PS: 0 ~ 1. Patients with an ECOG score of 2 ~ 3 due to bone pain alone, assessed by the investigator, were allowed to be included.
Histologically or cytologically confirmed stage IV Oligometastatic NSCLC (T1-3, N0-2, M1) according to The AJCC 8th edition TNM classification for lung cancer; The limitation of Oligometastatic was that the number of metastatic tumor foci ≤3 and only 1 organ was involved (excluding the primary organ). The involved metastatic organs were brain, liver, unilateral adrenal gland and bone.
Proved EGFR, ALK, ROS1 wild-type non-small cell lung cancer.
All patients should be evaluated by complete staging at baseline, and the confirmation of Qligometastases should include whole-body imaging (chest, abdominal, bone scan, or PET-CT).
Patients with brain metastases who are assessed by adjuvant staging with PET-CT or magnetic resonance imaging (MRI) at baseline and who are expected to receive or have received radical treatment for the metastases (LAT), which is assessed and administered by the MDT team and includes surgery, radiation therapy, or a combination of both, Patients who have received treatment for intracranial lesions should have achieved neurological stability (other than residual signs or symptoms associated with CNS treatment) for at least 2 weeks, and at least 4 weeks after initial treatment with the treatment protocol in this study.

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Exist in patients with bone metastases, baseline imaging should be carried out in accordance with the requirements of this study confirmed that always happens skeletal related events (pathologic fracture, bone radiation, surgery, or spinal cord compression), 4 words patients in stable condition, before the start of the study were allowed in, but it must be submitted to the team before treatment and the current state of disease management, to ensure that qualified cases, Patients with bone metastases are allowed to receive bisphosphonates unless contraindicated or not recommended by the investigator.
For patients with adrenal metastases, unilateral (non-primary) adrenal metastases should be confirmed by MRI or PET-CT at baseline and are expected to receive radical LAT therapy.
For patients with liver metastases, patients at baseline should meet adequate or good liver function without hepatic encephalopathy or ascites, and are expected to receive radical/partial radical therapy for liver Oligomastatic lesions.
Measurable target lesions were present at baseline according to RECIST 1.1 evaluation criteria.
Vital organ function meets the following requirements (no blood components or cell growth factors are allowed to be used for 2 weeks prior to the start of study treatment)：
blood routine:
ANC ≥1.5×109/L; b) HB ≥9 g/dL; c) PLT ≥90×109/L; d) ALB ≥2.8 g/dL.
Blood biochemistry:
TBIL ≤1.5 ULN; b) ALT、AST≤2.5 ULN (If abnormal liver function is caused by oligosaccharide metastasis, ≤5.0 ULN); c) sCr≤1.5 ULN, Endogenous creatinine clearance rate ≥50ml/min (Cockcroft-Gault formula); d) BUN ≤ 2.5 ULN; e) Normal thyroid function (if TSH is not within the normal range at baseline, and if T3 and free T4 are within the normal range, then subjects will still meet the inclusion criteria).
Expected survival ≥3 months.
Fertile female subjects should conduct a urine or serum pregnancy test within 7 days prior to receiving the first study drug administration and prove negative and be willing to use an effective method of contraception during the study period until 12 months after the last study drug administration. For male subjects whose partners are women of reproductive age, effective contraception should be used during the trial and for 12 months after the last dosing.
Patients voluntarily enrolled in this study and signed informed consent (ICF), with good compliance and follow-up.

Who cannot join

Subjects who meet any of the following criteria will be excluded from the study:
Non-small cell lung cancer patients who do not meet the inclusion criteria for pathological types and primary sites of the lung.
There are metastatic organs >1 kinds and metastatic lesions >3.
Exact evidence confirms the presence of EGFR, ALK, ROS 1 gene mutations in non-small cell lung cancer.
Have received systemic antitumor therapy or any other form of immune checkpoint inhibitor after diagnosis of stage IV Oligometastatic NSCLC.
By MDT assessment, the primary lung lesion is expected to be inoperable, the primary tumor or metastases result in direct invasion or clinically highly suspected direct invasion of the main vascular wall, or the presence of malignant pleural or pericardial effusion.

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The Oligometastases were identified by the investigators as secondary primary tumors.
Patients with brain metastases have proven to have CNS metastases and/or cancerous meningitis that, in the investigator's judgment, cannot be treated with radical treatment.
Patients with bone metastases have demonstrated prior or current signs of osteoporosis/osteomyelitis of the jaw, or a history of uncontrolled osteoporosis fractures.
Patients with liver metastases had hepatic encephalopathy in the past 6 months or clinically significant ascites at study enrollment.
Other serious, uncontrolled comorbidities that may affect protocol compliance or interfere with interpretation of results: (1) Active infection or unexplained fever of > 38.5℃ during screening or before first administration (subject fever due to tumor can be included as judged by the investigator); (2) uncontrolled diabetes mellitus; (3) Severe or uncontrolled cardiac clinical symptoms or diseases requiring treatment, such as NYHA Grade II or above heart failure; Unstable angina pectoral; Myocardial infarction occurred within 1 year; Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. (4) Pulmonary disease (interstitial pneumonia, obstructive pulmonary disease, and a history of symptomatic bronchospasm).
Active tuberculosis, hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV).
Except for active autoimmune diseases requiring systemic treatment: patients with a history of hypothyroidism who do not need hormone therapy or who are receiving physiological dose hormone replacement therapy; Subjects with stable type 1 diabetes with blood sugar under control.
Known to be allergic to pemetrexed, nab-paclitaxel, cisplatin, carboplatin or any of their prophylactic agents, or to any of the ingredients of toripalimab.
An antitumor monoclonal antibody (mAb) received within 4 weeks prior to initial study drug use, or an adverse event from a previous drug that has not recovered (i.e., grade 1 ≤ or at baseline). Note: Except for subjects with grade ≤2 neuropathy or grade ≤2 alopecia, if the subject has undergone major surgery, the toxicity and/or complications resulting from the surgical intervention must be fully recovered before treatment is initiated.
The live vaccine received within 4 weeks prior to the first use of the study drug is allowed to receive the inactivated virus vaccine for seasonal influenza by injection, but the live attenuated influenza vaccine administered through the nose is not allowed to receive.
As judged by the Investigator, the subjects have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors that may affect the subjects' safety or the data collection of the study.
Pregnant or lactating women, fertile men and women who were unwilling to use effective contraceptive methods during the study period.
Other conditions judged by the investigator to be unsuitable for inclusion in the study.

Trial locations and contacts

1 site in 1 country.

Jie Lei, PH.D contact

+86-029-84777777

leijiemd@163.com

China1 site, 1 recruiting

The Fourth Military Medical University Tangdu Hospital
Xi'an, Shaanxi, 710038
Jie Lei, PH.D, +86-029-84777777, leijiemd@163.com
Recruiting

Other trials in China

About this study

Official title: Toripalimab in Combination With Platinum-based Chemotherapy in Patients With Mutation-negative Stage IV Oligometastatic NSCLC: A Phase II Study.

In recent years, immune checkpoint inhibitors targeting cytotoxic T-lymphocyte antigen-4, programmed death-1, and programmed death-ligand 1 have achieved milestones in the treatment of NSCLC, from back-line to first-line, and beyond. Is changing the standard of care for NSCLC. Currently, several phases Ⅲ clinical studies of neoadjuvant immunity combined with standard chemotherapy are underway, suggested that neoadjuvant ICI therapy is a promising way for locally advanced lung cancer. As an intermediate state in the process of tumor metastasis, Oligometastatic NSCLC patients have a better prognosis and more likely to benefit from local treatment than patients with extensive distant metastasis. However, there have been few reports of salvage surgery after ICI treatment in Oligometastatic NSCLC, and only one case has been reported to date. There is therefore a need to further gather evidence on salvage surgery after ICI.

Read the detailed description

This is a single-center, single-arm, prospective phase II study to evaluate the efficacy and safety of toripalimab in combination with platinum-based and surgery in patients with mutation-negative stage IV Oligometastatic NSCLC.

Conditions: NSCLC Stage IV, Oligometastasis
Being tested: Toripalimab in Combination With Platinum-based Chemotherapy, Surgical treatment stage, Adjuvant treatment stage
Keywords: anti-PD-1, Toripalimab
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.

Toripalimab in Combination With Platinum-based ChemotherapyDrug
Also called Toripalimab Injection, JS001, Teruipuli Dankang, TuoYI
Toripalimab will be administered at a fixed dose of 80 mg (2ml)/vial, IV, D1, with a full dose of 240 mg at one time, every 3 weeks for 3-4 cycles. Squamous cell carcinoma will be combined with cisplatin/carboplatin and Nab-paclitaxel: carboplatin, AUC=5, D1, IV, q3w, or cisplatin, 75 mg/m2, IV, q3w, and Nab-paclitaxel, 130 mg/m2, D1, IV, q3w, for 3-4 cycles. Non-squamous cell carcinoma will be combined with cisplatin/carboplatin and Pemetrexed, cisplatin/carboplatin is the same as above, Pemetrexed will be given at 500 mg/m2, D1, IV, q3w, for 3-4 cycles.
Surgical treatment stageProcedure or surgery
After the last treatment (Day 21 of Cycle 4), surgery was performed within 4-6 weeks.
Adjuvant treatment stageDrug
Also called Toripalimab Injection, JS001, Teruipuli Dankang, TuoYI
Postoperatively, a comprehensive evaluation will be conducted by the investigator, and the intention will receive maintenance therapy within 6-12 weeks of the MDT assessment. Toripalimab: a fixed dose of 80 mg (2ml)/vial, IV, D1, a full dose of 240 mg at one time, every 3 weeks administered until PD or intolerable toxicity, for a maximum duration of 1 year.

Study groups in NCT05055583
Study group	Role	What they receive
Toripalimab in Combination With Platinum-based Chemotherapy	Experimental	Participants receive totally 3-4 cycles of toripalimab combined with platinum-based chemotherapy neoadjuvant treatment during preoperative period. After the last treatment (Day 21 of Cycle 4), surgery will be performed within 4-6 weeks. Postoperatively, a comprehensive evaluation will be conducted by the investigator, and the intention was to receive maintenance therapy within 6-12 weeks of the MDT assessment. Receives: Drug: Toripalimab in Combination With Platinum-based Chemotherapy; Procedure: Surgical treatment stage; Drug: Adjuvant treatment stage

What is being measured

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

Progress Free Survival(PFS)
Progress Free Survival is defined as included the development of new metastases, or local progression of metastases or primary lesions that underwent surgical resection/radiotherapy and will be assessed according to RESIST 1.1 criteria.
Measured: the time from the date of the operation until the first recurrence or the last follow-up(Up to approximately 26 months).

Secondary outcomes (4)

Pathological complete response(pCR)
Pathological complete response is defined as 0% survival of tumor cells in surgically resected primary and metastatic tumor samples (excluding brain and bone metastases) after neoadjuvant therapy, as assessed by tumor regression grade.
Measured: after 3-4 cycles of neoadjuvant therapy (At the day of surgery)
Main pathology rate(MPR)
Main pathology rate is defined as survival of tumor cells ≤ 10% in surgically resected primary and metastatic tumor samples (excluding brain and bone metastases) after neoadjuvant therapy, assessed by tumor regression grade.
Measured: after 3-4 cycles of neoadjuvant therapy (At the day of surgery)
Objective Response Rate (ORR)
Objective Response Rate is defined as complete response (CR) + partial response (PR), from the beginning of regimental therapy to the end of neoadjuvant therapy, the efficacy of baseline target lesions (primary + metastatic) was assessed by RECIST1.1 criteria.
Measured: after 3-4 cycles of neoadjuvant therapy(Up to approximately 26 months).
Assess adverse events
Assess all adverse events according to the NCI Common Terminology Criteria for (NCI-CTCAE) v 4.0.3.
Measured: the time from the neoadjuvant until the last follow-up(Up to approximately 26 months).

Timeline

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

31 Aug 202131 Dec 2023

First posted24 Sep 2021
Study start31 Aug 2021
Primary completion31 Aug 2023 (estimated)
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLC Stage IVStudies 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: Not applicable
Intervention model: Single group
Model description: Single-arm, sigle-center, prospective phase II study.
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05055583
Sponsor's protocol ID: JS001-ISS-CO338
Status last verified: Sep 2021
First submitted: 29 Aug 2021
Last updated: 24 Sep 2021
Results posted: No
Data monitoring committee: 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 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Toripalimab in Combination With Platinum-based Chemotherapy in Patients With Mutation-negative Stage IV Oligometastatic NSCLC: A Phase II Study.
ClinicalTrials.gov ID: NCT05055583
Acronym / sponsor ID: JS001-ISS-CO338
Conditions: NSCLC Stage IV, Oligometastasis
Keywords: anti-PD-1, Toripalimab
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Tang-Du HospitalUniversity, hospital or other
Study start: 31 Aug 2021 (actual)
Primary completion: 31 Aug 2023 (estimated)
Study completion: 31 Dec 2023 (estimated)
First posted: 24 Sep 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single-arm, sigle-center, prospective phase II study.

Arm	Type	Receives
Toripalimab in Combination With Platinum-based Chemotherapy	Experimental	Drug: Toripalimab in Combination With Platinum-based Chemotherapy, Procedure: Surgical treatment stage, Drug: Adjuvant treatment stageParticipants receive totally 3-4 cycles of toripalimab combined with platinum-based chemotherapy neoadjuvant treatment during preoperative period. After the last treatment (Day 21 of Cycle 4), surgery will be performed within 4-6 weeks. Postoperatively, a comprehensive evaluation will be conducted by the investigator, and the intention was to receive maintenance therapy within 6-12 weeks of the MDT assessment.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Age: 18 ~ 70 years old, male or female.
ECOG PS: 0 ~ 1. Patients with an ECOG score of 2 ~ 3 due to bone pain alone, assessed by the investigator, were allowed to be included.
Histologically or cytologically confirmed stage IV Oligometastatic NSCLC (T1-3, N0-2, M1) according to The AJCC 8th edition TNM classification for lung cancer; The limitation of Oligometastatic was that the number of metastatic tumor foci ≤3 and only 1 organ was involved (excluding the primary organ). The involved metastatic organs were brain, liver, unilateral adrenal gland and bone.
Proved EGFR, ALK, ROS1 wild-type non-small cell lung cancer.
All patients should be evaluated by complete staging at baseline, and the confirmation of Qligometastases should include whole-body imaging (chest, abdominal, bone scan, or PET-CT).

Key exclusion criteria (19 listed)

Non-small cell lung cancer patients who do not meet the inclusion criteria for pathological types and primary sites of the lung.
There are metastatic organs >1 kinds and metastatic lesions >3.
Exact evidence confirms the presence of EGFR, ALK, ROS 1 gene mutations in non-small cell lung cancer.
Have received systemic antitumor therapy or any other form of immune checkpoint inhibitor after diagnosis of stage IV Oligometastatic NSCLC.
By MDT assessment, the primary lung lesion is expected to be inoperable, the primary tumor or metastases result in direct invasion or clinically highly suspected direct invasion of the main vascular wall, or the presence of malignant pleural or pericardial effusion.

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
Toripalimab in Combination With Platinum-based ChemotherapyAlso: Toripalimab Injection, JS001, Teruipuli Dankang, TuoYIToripalimab will be administered at a fixed dose of 80 mg (2ml)/vial, IV, D1, with a full dose of 240 mg at one time, every 3 weeks for 3-4 cycles. Squamous cell carcinoma will be combined with cisplatin/carboplatin and Nab-paclitaxel: carboplatin, AUC=5, D1, IV, q3w, or cisplatin, 75 mg/m2, IV, q3w, and Nab-paclitaxel, 130 mg/m2, D1, IV, q3w, for 3-4 cycles. Non-squamous cell carcinoma will be combined with cisplatin/carboplatin and Pemetrexed, cisplatin/carboplatin is the same as above, Pemetrexed will be given at 500 mg/m2, D1, IV, q3w, for 3-4 cycles.	Drug	Toripalimab in Combination With Platinum-based Chemotherapy
Surgical treatment stageAfter the last treatment (Day 21 of Cycle 4), surgery was performed within 4-6 weeks.	Procedure or surgery	Toripalimab in Combination With Platinum-based Chemotherapy
Adjuvant treatment stageAlso: Toripalimab Injection, JS001, Teruipuli Dankang, TuoYIPostoperatively, a comprehensive evaluation will be conducted by the investigator, and the intention will receive maintenance therapy within 6-12 weeks of the MDT assessment. Toripalimab: a fixed dose of 80 mg (2ml)/vial, IV, D1, a full dose of 240 mg at one time, every 3 weeks administered until PD or intolerable toxicity, for a maximum duration of 1 year.	Drug	Toripalimab in Combination With Platinum-based Chemotherapy

Primary outcome

Progress Free Survival(PFS)
Time frame: the time from the date of the operation until the first recurrence or the last follow-up(Up to approximately 26 months).
Progress Free Survival is defined as included the development of new metastases, or local progression of metastases or primary lesions that underwent surgical resection/radiotherapy and will be assessed according to RESIST 1.1 criteria.

4 secondary outcomes

Pathological complete response(pCR)
Time frame: after 3-4 cycles of neoadjuvant therapy (At the day of surgery)
Main pathology rate(MPR)
Time frame: after 3-4 cycles of neoadjuvant therapy (At the day of surgery)
Objective Response Rate (ORR)
Time frame: after 3-4 cycles of neoadjuvant therapy(Up to approximately 26 months).
Assess adverse events
Time frame: the time from the neoadjuvant until the last follow-up(Up to approximately 26 months).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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.

Jie Lei, PH.D contact

+86-029-84777777

leijiemd@163.com

Tao Jiang, PH.D principal investigator

The Fourth Military Medical University Tangdu Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 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 24 Sep 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 Jie Lei, PH.D (+86-029-84777777, leijiemd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress Free Survival(PFS) (time frame: the time from the date of the operation until the first recurrence or the last follow-up(Up to approximately 26 months).). 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 NCT05055583.

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 24 Sep 2021.