Non-Small Cell Lung CancerPhase 2NCT06718309

Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC

A Phase 2 study testing Chemotherapy, Immunotherapy and Radical resection of lung cancer in people with Non-Small Cell Lung Cancer, run by First People's Hospital of Hangzhou at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Chemotherapy, Immunotherapy and Radical resection of lung cancer
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 24 Apr 2024to 30 Apr 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients;
Age ≥18 years;
(Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1;
According to the 8th-9th edition of (American Joint Committee on Cancer, AJCC) (stage II-IIIA, for stage IIIB included T3-4N2, T4 only included tumor > 7cm);
Puncture or biopsy samples were tested EGFR/ALK negative;
Surgically or potentially resectable after discussion by multidisciplinary team (MDT);

Show all 11Show fewer

Who has not received systemic antitumor therapy and has not received chest radiotherapy;
Evaluable lesions in the lung or mediastinum;
The organ function level should meet the following criteria one week before enrollment: 1) Bone marrow function: hemoglobin ≥80g/L, white blood cell count ≥4.0*10^9/L or neutrophil count ≥1.5*10^9/L, platelet count ≥100*10^9/L; 2) Liver: total serum bilirubin level ≤1.5 times the normal upper limit, when serum total bilirubin level > 1.5 times the normal upper limit, direct bilirubin level ≤ normal upper limit, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the normal upper limit; 3) Kidney: blood creatinine level < 1.5 times the normal upper limit or creatinine clearance ≥50ml/min, urea nitrogen ≤200mg/L; Serum albumin ≥30g/L;
Male/female of childbearing age agrees to use contraception during the trial period (surgical ligation or oral contraceptives/IUDs + condom contraception);
Sign informed consent.

Who cannot join

Patients with severe dysfunctions of the heart, lungs and other organs who are not suitable for surgery;
Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc;
Other malignancies within 5 years (excluding non-melanoma skin cancer and cervical cancer);
Patient with active infection, heart failure, heart attack, unstable angina pectoris or unstable arrhythmia within the last 6 months;
Congenital or acquired immunodeficiency disorders include human immunodeficiency virus (HIV) or a history of organ transplantation or allogeneic stem cell transplantation;
Patients treated with other immunological agents, chemotherapy agents, other drugs in clinical trials and long-term cortisol therapy were excluded;
Patients who are allergic or contraindicated to PD-1 inhibitors.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yi Tang contact

86-15068763710

Beebee24@163.com

China1 site, 1 recruiting

Department of Thoracic Oncology, Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002
Lihui Fang, 86-571-56006035, 1508590739@qq.com
Lucheng Zhu, MD
Recruiting

Other trials in China

About this study

Official title: A Prospective Cohort Study of Chemotherapy Plus Immunotherapy Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Patients With Resectable Non-small Cell Lung Cancer

Conditions: Non-Small Cell Lung Cancer
Being tested: Chemotherapy, Immunotherapy, Radical resection of lung cancer, SBRT
Keywords: NSCLC, locally advanced, resectable, SBRT, immunotherapy
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.

ChemotherapyDrug
Patients with squamous cell carcinoma can choose paclitaxel + cisplatin/carboplatin and patients with nonsquamous cell carcinoma can choose pemetrexed + cisplatin/carboplatin. The chemotherapy treatment lasts 3 cycles.
ImmunotherapyDrug
Investigators choose PD-1 or PD-L1 according to drug indication and the immunotherapy lasts 3 cycles preoperatively and 1 year after surgery.
Radical resection of lung cancerProcedure or surgery
Radical resection of lung cancer with lymph node dissection
SBRTRadiation
SBRT for primary lung lesion 8Gy*3F after first cycle of chemoimmunotherapy

Study groups in NCT06718309
Study group	Role	What they receive
Treatment group	Experimental	Treatment group Receives: Drug: Chemotherapy; Drug: Immunotherapy; Procedure: Radical resection of lung cancer; Radiation: SBRT

What is being measured

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

Pathological complete response (pCR)
Pathological complete response for surgical patients
Measured: Assessed up to 24 weeks

Secondary outcomes (4)

Major pathologic response (MPR)
No more than 10% residual viable tumour in the resected tumour (up to 24 weeks)
Measured: Assessed up to 24 weeks
1-year event-free survival (1 year EFS)
Interval between the start of neoadjuvant treatment and any progression of disease precluding surgical resection, progression of disease in the absence of surgery, progression or recurrence after surgery, or death from any cause, whichever occurred first
Measured: Assessed up to 100 months
The R0 resection rate
The proportion of patients who had complete surgical resection [R0]
Measured: Assessed up to 24 weeks
Incidence of treatment-related adverse events
The incidence of adverse events ≥ grade 3 during perioperative period
Measured: assessed up to 100 months

Timeline

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

24 Apr 202430 Apr 2029

First posted5 Dec 2024
Study start24 Apr 2024
Primary completion30 Apr 2027 (estimated)
Study completion30 Apr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell Lung CancerStudies 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: In this study, patients with surgically resectable locally advanced non-small cell lung cancer (stage II-IIIA and part of stage IIIB) (EGFR/ALK wild-type for adenocarcinoma patients) are enrolled. Eligible patients firstly receive one cycle of chemoimmunotherapy, followed by stereotactic body radiotherapy (SBRT) (8Gy\*3F) to the primary lung lesion and then continued with another two cycles of chemoimmunotherapy. Surgical treatment was performed within 4-6 weeks after the last chemoimmunotherapy. Immunotherapy continues until 1 year after surgery. Minimal residue lesion (MRD) are monitored at 5 timepoints during the treatment period.
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06718309
Sponsor's protocol ID: HZCH-2024-003
Status last verified: Nov 2024
First submitted: 24 Nov 2024
Last updated: 5 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang JT, Liu SY, Gao W, Liu SM, Yan HH, Ji L, Chen Y, Gong Y, Lu HL, Lin JT, Yin K, Jiang BY, Nie Q, Liao RQ, Dong S, Guan Y, Dai P, Zhang XC, Yang JJ, Tu HY, Xia X, Yi X, Zhou Q, Zhong WZ, Yang XN, Wu YL. Longitudinal Undetectable Molecular Residual Disease Defines Potentially Cured Population in Localized Non-Small Cell Lung Cancer. Cancer Discov. 2022 Jul 6;12(7):1690-1701. doi: 10.1158/2159-8290.CD-21-1486.
PubMed 35543554
Xia L, Mei J, Kang R, Deng S, Chen Y, Yang Y, Feng G, Deng Y, Gan F, Lin Y, Pu Q, Ma L, Lin F, Yuan Y, Hu Y, Guo C, Liao H, Liu C, Zhu Y, Wang W, Liu Z, Xu Y, Li K, Li C, Li Q, He J, Chen W, Zhang X, Kou Y, Wang Y, Wu Z, Che G, Chen L, Liu L. Perioperative ctDNA-Based Molecular Residual Disease Detection for Non-Small Cell Lung Cancer: A Prospective Multicenter Cohort Study (LUNGCA-1). Clin Cancer Res. 2022 Aug 2;28(15):3308-3317. doi: 10.1158/1078-0432.CCR-21-3044.
PubMed 34844976
Qiu B, Guo W, Zhang F, Lv F, Ji Y, Peng Y, Chen X, Bao H, Xu Y, Shao Y, Tan F, Xue Q, Gao S, He J. Dynamic recurrence risk and adjuvant chemotherapy benefit prediction by ctDNA in resected NSCLC. Nat Commun. 2021 Nov 19;12(1):6770. doi: 10.1038/s41467-021-27022-z.
PubMed 34799585
Galluzzi L, Aryankalayil MJ, Coleman CN, Formenti SC. Emerging evidence for adapting radiotherapy to immunotherapy. Nat Rev Clin Oncol. 2023 Aug;20(8):543-557. doi: 10.1038/s41571-023-00782-x. Epub 2023 Jun 6.
PubMed 37280366
Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):491-503. doi: 10.1056/NEJMoa2302983. Epub 2023 Jun 3.
PubMed 37272513

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Cohort Study of Chemotherapy Plus Immunotherapy Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Patients With Resectable Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06718309
Acronym / sponsor ID: HZCH-2024-003
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC, locally advanced, resectable, SBRT, immunotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: First People's Hospital of HangzhouUniversity, hospital or other
Study start: 24 Apr 2024 (actual)
Primary completion: 30 Apr 2027 (estimated)
Study completion: 30 Apr 2029 (estimated)
First posted: 5 Dec 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: In this study, patients with surgically resectable locally advanced non-small cell lung cancer (stage II-IIIA and part of stage IIIB) (EGFR/ALK wild-type for adenocarcinoma patients) are enrolled. Eligible patients firstly receive one cycle of chemoimmunotherapy, followed by stereotactic body radiotherapy (SBRT) (8Gy*3F) to the primary lung lesion and then continued with another two cycles of chemoimmunotherapy. Surgical treatment was performed within 4-6 weeks after the last chemoimmunotherapy. Immunotherapy continues until 1 year after surgery. Minimal residue lesion (MRD) are monitored at 5 timepoints during the treatment period.

Arm	Type	Receives
Treatment group	Experimental	Drug: Chemotherapy, Drug: Immunotherapy, Procedure: Radical resection of lung cancer, Radiation: SBRTTreatment group

Who may qualify

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

Key inclusion criteria (11 listed)

Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients;
Age ≥18 years;
(Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1;
According to the 8th-9th edition of (American Joint Committee on Cancer, AJCC) (stage II-IIIA, for stage IIIB included T3-4N2, T4 only included tumor > 7cm);
Puncture or biopsy samples were tested EGFR/ALK negative;

Key exclusion criteria (7 listed)

Patients with severe dysfunctions of the heart, lungs and other organs who are not suitable for surgery;
Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc;
Other malignancies within 5 years (excluding non-melanoma skin cancer and cervical cancer);
Patient with active infection, heart failure, heart attack, unstable angina pectoris or unstable arrhythmia within the last 6 months;
Congenital or acquired immunodeficiency disorders include human immunodeficiency virus (HIV) or a history of organ transplantation or allogeneic stem cell transplantation;

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
ChemotherapyPatients with squamous cell carcinoma can choose paclitaxel + cisplatin/carboplatin and patients with nonsquamous cell carcinoma can choose pemetrexed + cisplatin/carboplatin. The chemotherapy treatment lasts 3 cycles.	Drug	Treatment group
ImmunotherapyInvestigators choose PD-1 or PD-L1 according to drug indication and the immunotherapy lasts 3 cycles preoperatively and 1 year after surgery.	Drug	Treatment group
Radical resection of lung cancerRadical resection of lung cancer with lymph node dissection	Procedure or surgery	Treatment group
SBRTSBRT for primary lung lesion 8Gy*3F after first cycle of chemoimmunotherapy	Radiation	Treatment group

Primary outcome

Pathological complete response (pCR)
Time frame: Assessed up to 24 weeks
Pathological complete response for surgical patients

4 secondary outcomes

Major pathologic response (MPR)
Time frame: Assessed up to 24 weeks
1-year event-free survival (1 year EFS)
Time frame: Assessed up to 100 months
The R0 resection rate
Time frame: Assessed up to 24 weeks
Incidence of treatment-related adverse events
Time frame: assessed up to 100 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
Results publication: PubMed 35543554Zhang JT, Liu SY, Gao W, Liu SM, Yan HH, Ji L, Chen Y, Gong Y, Lu HL, Lin JT, Yin K, Jiang BY, Nie Q, Liao RQ, Dong S, Guan Y, Dai P, Zhang XC, Yang JJ, Tu HY, Xia X, Yi X, Zhou Q, Zhong WZ, Yang XN, Wu YL. Longitudinal Undetectable Molecular Residual Disease Defines Potentially Cured Population in Localized Non-Small Cell Lung Cancer. Cancer Discov. 2022 Jul 6;12(7):1690-1701. doi: 10.1158/2159-8290.CD-21-1486.
Results publication: PubMed 34844976Xia L, Mei J, Kang R, Deng S, Chen Y, Yang Y, Feng G, Deng Y, Gan F, Lin Y, Pu Q, Ma L, Lin F, Yuan Y, Hu Y, Guo C, Liao H, Liu C, Zhu Y, Wang W, Liu Z, Xu Y, Li K, Li C, Li Q, He J, Chen W, Zhang X, Kou Y, Wang Y, Wu Z, Che G, Chen L, Liu L. Perioperative ctDNA-Based Molecular Residual Disease Detection for Non-Small Cell Lung Cancer: A Prospective Multicenter Cohort Study (LUNGCA-1). Clin Cancer Res. 2022 Aug 2;28(15):3308-3317. doi: 10.1158/1078-0432.CCR-21-3044.
Results publication: PubMed 34799585Qiu B, Guo W, Zhang F, Lv F, Ji Y, Peng Y, Chen X, Bao H, Xu Y, Shao Y, Tan F, Xue Q, Gao S, He J. Dynamic recurrence risk and adjuvant chemotherapy benefit prediction by ctDNA in resected NSCLC. Nat Commun. 2021 Nov 19;12(1):6770. doi: 10.1038/s41467-021-27022-z.
Results publication: PubMed 37280366Galluzzi L, Aryankalayil MJ, Coleman CN, Formenti SC. Emerging evidence for adapting radiotherapy to immunotherapy. Nat Rev Clin Oncol. 2023 Aug;20(8):543-557. doi: 10.1038/s41571-023-00782-x. Epub 2023 Jun 6.
Results publication: PubMed 37272513Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):491-503. doi: 10.1056/NEJMoa2302983. Epub 2023 Jun 3.
Individual participant dataSharing planned: No

Related trials for Non-Small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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.

Yi Tang contact

86-15068763710

Beebee24@163.com

Lucheng Zhu, MD principal investigator

Hangzhou Cancer Hospital

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 Chemotherapy, Immunotherapy and Radical resection of lung cancer in people with Non-Small Cell Lung Cancer, run by First People's Hospital of Hangzhou 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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Dec 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi Tang (86-15068763710, Beebee24@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) (time frame: Assessed up to 24 weeks). 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 NCT06718309, which also lists 5 linked publications.

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 5 Dec 2024.