Stage III Non-small Cell Lung CancerPhase 2NCT05468242

Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy

A Phase 2 study testing Neoadjuvant chemo-immunotherapy, Bevacizumab and Radiotherapy in people with Stage III Non-small Cell Lung Cancer, run by Sun Yat-sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial summary

The phase II Study is to explore the efficacy and safety of Tislelizumab as consolidation therapy in patients with locally advanced non-small cell lung cancer who have not progressed following neoadjuvant chemotherapy plus Tislelizumab ± Bevacizumab and definitive concurrent chemoradiation therapy. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Stage III Non-small Cell Lung Cancer
What is being tested?: Neoadjuvant chemo-immunotherapy, Bevacizumab and Radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteChina
Study dates: 1 Jan 2022to 30 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

For inclusion in neoadjuvant therapy, patients should fulfil the following criteria:
Provision of signed, written and dated informed consent prior to any study specific procedures;
Male or female aged 18~75 years old;
Patients must have histologically- or cytologically-documented NSCLC who present with locally advanced (Stage III) disease;
Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy;
A recent tumour biopsy (taken following completion of the most recent therapy) is an optional requirement, provided that a biopsy procedure is technically feasible and the procedure is not associated with unacceptable clinical risk;

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Life expectancy ≥12 weeks;
World Health Organization (WHO) Performance Status of 0 or 1;
Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients within 14 days before the use of study drug (HCG has a minimum sensitivity of 25 IU/L or equivalent);
Women must be non-breastfeeding
Forced expiratory volume in 1 second (FEV1) ≥800ml
Absolute neutrophil count >1.5 x 109/L (1500 per mm3)
Platelets >100 x 109/L (100,000 per mm3)
Haemoglobin≥9.0 g/dL (5.59 mmol/L)
Serum creatinine clearance(CL) >50 mL/min by the Cockcroft-Gault formula (Cockcroft and -Gault 1976)
Serum bilirubin ≤1.5 x upper limit of normal (ULN). Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤2.5 x ULN

Who cannot join

Exclusion criteria for enrolment for neoadjuvant therapy Patients should not enter the study if any of the following exclusion criteria are fulfilled:
Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;
Mixed small cell and non-small cell lung cancer histology;
Current or prior use of immunosuppressive medication within 28 days before the first dose of Tislelizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for NSCLC is allowed.
Prior exposure to any anti-programmed cell death protein(PD)-1 or anti-PD-L1 antibody;
Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of Tislelizumab;

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Active or prior documented autoimmune disease within the past 2 years;
Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);
History of primary immunodeficiency;
History of organ transplant that requires therapeutic immunosuppression;
The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava)
Bleeding tendency or coagulation disorder
Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months
Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg)
Major surgery within 28 days or minor surgery or needle biopsy within 48 hours
Urine protein 3-4+, or 24h urine protein quantitative >1g
Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Bazett's Correction;
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent;
Known history of tuberculosis;
Receipt of live attenuated vaccination within 30 days prior to study entry or within30 days of receiving Tislelizumab;
History of another primary malignancy within 5 years prior to starting Tislelizumab, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control;
Any condition that, in the opinion of the investigator, would interfere with evaluation of the Tislelizumab or interpretation of patient safety or study results.
Exclusion criteria for concurrent chemoradiation following neoadjuvant therapy
Patients should not enter the concurrent chemoradiation phase if any of the following exclusion criteria are fulfilled:
Patients who develop disease progression and the irradiation dose of normal tissue will exceed the limit as defined in Section 7.
World Health Organization (WHO) Performance Status of 2-4;
Inadequate organ and marrow function as defined below:
Forced expiratory volume in 1 second (FEV1) <800ml
Absolute neutrophil count <1.5 x 109/L (1500 per mm3)
Platelets <100 x 109/L (100,000 per mm3)
Haemoglobin<9.0 g/dL (5.59 mmol/L)
Serum creatinine CL <50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976)
Serum bilirubin >1.5 x upper limit of normal (ULN).
Aspartate Transaminase(AST) and Alanine Transaminase(ALT) >2.5 x ULN
Further exclusion criteria for Tislelizumab consolidation:
Patients should not enter the Tislelizumab consolidation if any of the following exclusion criteria are fulfilled:
Patients who have progressed whilst definitive platinum based, concurrent chemoradiation therapy;
Current or prior use of immunosuppressive medication within 28 days before the first dose of Tislelizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy will be excluded from randomization;
Patients with Grade ≥2 pneumonitis from prior chemoradiation therapy will be excluded from randomization; Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE>Grade 1.

Trial locations and contacts

1 site in 1 country.

Bo Qiu, MD contact

+86-020-87343031

qiubo@sysucc.org.cn

DaQuan Wang, MD contact

+86-020-87343031

wangdq@sysucc.org.cn

China1 site, 1 recruiting

Sun Yat-sen University
Guangzhou, 510060
Hui Liu, Professor, +86-020-87343031, liuhui@sysucc.org.cn
Recruiting

Other trials in China

About this study

Official title: A Phase II Trial of Tislelizumab as Consolidation Therapy in Patients With Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy

Conditions: Stage III Non-small Cell Lung Cancer
Being tested: Neoadjuvant chemo-immunotherapy, Bevacizumab, Radiotherapy, Tislelizumab
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.

Neoadjuvant chemo-immunotherapyDrug
The neoadjuvant chemo-immunotherapy before radiotherapy comprised of chemotherapy plus Tislelizumab [200 mg, once every 3 weeks (Q3W)].
BevacizumabDrug
The Bevacizumab was administrated concurrently with neoadjuvant chemo-immunotherapy (7.5mg/kg) once every 3 weeks (Q3W).
RadiotherapyRadiation
Definitive radiotherapy to the thoracic lesions.
TislelizumabDrug
Tislelizumab consolidation (200 mg) is performed once every 3 weeks after the neoadjuvant therapy and concurrent chemo-radiotherapy, and will continue on a Q3W schedule for a maximum duration of 12 months.

Study groups in NCT05468242
Study group	Role	What they receive
Neoadjuvant Chemotherapy Plus Tislelizumab + Bevacizumab	Experimental	Patients in experimental group will receive Tislelizumab consolidation (200 mg/q3w) after the neoadjuvant chemotherapy plus Tislelizumab + Bevacizumab and concurrent chemoradiotherapy. Receives: Drug: Neoadjuvant chemo-immunotherapy; Drug: Bevacizumab; Radiation: Radiotherapy; Drug: Tislelizumab
Neoadjuvant Chemotherapy Plus Tislelizumab	Active comparator	Patients in this group will receive Tislelizumab consolidation (200 mg/q3w) after the neoadjuvant chemotherapy plus Tislelizumab and concurrent chemoradiotherapy. Receives: Drug: Neoadjuvant chemo-immunotherapy; Radiation: Radiotherapy; Drug: Tislelizumab

What is being measured

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

Progression free survival
From the start date of initial treatment to progression, death or last follow-up.
Measured: 2-year

Secondary outcomes (4)

Overall survival
From the start date of initial treatment to death or to last follow-up.
Measured: 2-year
Adverse Event
Toxicities were evaluated using the CTCAE 5.0
Measured: 2-year
Health-related Quality of Life
An individual's or perceived physical and mental health during and after treatment.
Measured: 2-year
Objective response rate
Tumor response to neoadjuvant immuno-chemotherapy and radiotherapy based on RECIST 1.1
Measured: 2-year

Timeline

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

1 Jan 202230 Dec 2024

First posted21 Jul 2022
Study start1 Jan 2022
Primary completion30 Dec 2024 (estimated)
Study completion30 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Stage III Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 116 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05468242
Sponsor's protocol ID: GASTO-1086
Status last verified: Oct 2024
First submitted: 19 Jul 2022
Last updated: 30 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bezjak A, Temin S, Franklin G, Giaccone G, Govindan R, Johnson ML, Rimner A, Schneider BJ, Strawn J, Azzoli CG. Definitive and Adjuvant Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Society for Radiation Oncology Evidence-Based Clinical Practice Guideline. J Clin Oncol. 2015 Jun 20;33(18):2100-5. doi: 10.1200/JCO.2014.59.2360. Epub 2015 May 5.
PubMed 25944914
Machtay M, Bae K, Movsas B, Paulus R, Gore EM, Komaki R, Albain K, Sause WT, Curran WJ. Higher biologically effective dose of radiotherapy is associated with improved outcomes for locally advanced non-small cell lung carcinoma treated with chemoradiation: an analysis of the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):425-34. doi: 10.1016/j.ijrobp.2010.09.004. Epub 2010 Oct 25.
PubMed 20980108
Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
PubMed 28885881
Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
PubMed 29658848
Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.
PubMed 32979984
Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Ozguroglu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346.
PubMed 32997907
Zhang YQ, Hu PC, Wu RZ, Gu YS, Chen SG, Yu HJ, Wang XQ, Song J, Shi HC. The image quality, lesion detectability, and acquisition time of 18F-FDG total-body PET/CT in oncological patients. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2507-2515. doi: 10.1007/s00259-020-04823-w. Epub 2020 May 18.
PubMed 32424483

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Trial of Tislelizumab as Consolidation Therapy in Patients With Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy
ClinicalTrials.gov ID: NCT05468242
Acronym / sponsor ID: GASTO-1086
Conditions: Stage III Non-small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 116 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 1 Jan 2022 (actual)
Primary completion: 30 Dec 2024 (estimated)
Study completion: 30 Dec 2024 (estimated)
First posted: 21 Jul 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Neoadjuvant Chemotherapy Plus Tislelizumab + Bevacizumab	Experimental	Drug: Neoadjuvant chemo-immunotherapy, Drug: Bevacizumab, Radiation: Radiotherapy, Drug: TislelizumabPatients in experimental group will receive Tislelizumab consolidation (200 mg/q3w) after the neoadjuvant chemotherapy plus Tislelizumab + Bevacizumab and concurrent chemoradiotherapy.
Neoadjuvant Chemotherapy Plus Tislelizumab	Active comparator	Drug: Neoadjuvant chemo-immunotherapy, Radiation: Radiotherapy, Drug: TislelizumabPatients in this group will receive Tislelizumab consolidation (200 mg/q3w) after the neoadjuvant chemotherapy plus Tislelizumab and concurrent chemoradiotherapy.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

For inclusion in neoadjuvant therapy, patients should fulfil the following criteria:

Key exclusion criteria (41 listed)

Exclusion criteria for enrolment for neoadjuvant therapy Patients should not enter the study if any of the following exclusion criteria are fulfilled:
Exclusion criteria for concurrent chemoradiation following neoadjuvant therapy
Patients should not enter the concurrent chemoradiation phase if any of the following exclusion criteria are fulfilled:
Patients who develop disease progression and the irradiation dose of normal tissue will exceed the limit as defined in Section 7.
World Health Organization (WHO) Performance Status of 2-4;

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
Neoadjuvant chemo-immunotherapyThe neoadjuvant chemo-immunotherapy before radiotherapy comprised of chemotherapy plus Tislelizumab [200 mg, once every 3 weeks (Q3W)].	Drug	Neoadjuvant Chemotherapy Plus Tislelizumab, Neoadjuvant Chemotherapy Plus Tislelizumab + Bevacizumab
BevacizumabThe Bevacizumab was administrated concurrently with neoadjuvant chemo-immunotherapy (7.5mg/kg) once every 3 weeks (Q3W).	Drug	Neoadjuvant Chemotherapy Plus Tislelizumab + Bevacizumab
RadiotherapyDefinitive radiotherapy to the thoracic lesions.	Radiation	Neoadjuvant Chemotherapy Plus Tislelizumab, Neoadjuvant Chemotherapy Plus Tislelizumab + Bevacizumab
TislelizumabTislelizumab consolidation (200 mg) is performed once every 3 weeks after the neoadjuvant therapy and concurrent chemo-radiotherapy, and will continue on a Q3W schedule for a maximum duration of 12 months.	Drug	Neoadjuvant Chemotherapy Plus Tislelizumab, Neoadjuvant Chemotherapy Plus Tislelizumab + Bevacizumab

Primary outcome

Progression free survival
Time frame: 2-year
From the start date of initial treatment to progression, death or last follow-up.

4 secondary outcomes

Overall survival
Time frame: 2-year
Adverse Event
Time frame: 2-year
Health-related Quality of Life
Time frame: 2-year
Objective response rate
Time frame: 2-year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
Background: PubMed 25944914Bezjak A, Temin S, Franklin G, Giaccone G, Govindan R, Johnson ML, Rimner A, Schneider BJ, Strawn J, Azzoli CG. Definitive and Adjuvant Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Society for Radiation Oncology Evidence-Based Clinical Practice Guideline. J Clin Oncol. 2015 Jun 20;33(18):2100-5. doi: 10.1200/JCO.2014.59.2360. Epub 2015 May 5.
Results publication: PubMed 20980108Machtay M, Bae K, Movsas B, Paulus R, Gore EM, Komaki R, Albain K, Sause WT, Curran WJ. Higher biologically effective dose of radiotherapy is associated with improved outcomes for locally advanced non-small cell lung carcinoma treated with chemoradiation: an analysis of the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):425-34. doi: 10.1016/j.ijrobp.2010.09.004. Epub 2010 Oct 25.
Results publication: PubMed 28885881Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
Results publication: PubMed 29658848Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
Results publication: PubMed 32979984Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.
Results publication: PubMed 32997907Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Ozguroglu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346.
Results publication: PubMed 32424483Zhang YQ, Hu PC, Wu RZ, Gu YS, Chen SG, Yu HJ, Wang XQ, Song J, Shi HC. The image quality, lesion detectability, and acquisition time of 18F-FDG total-body PET/CT in oncological patients. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2507-2515. doi: 10.1007/s00259-020-04823-w. Epub 2020 May 18.
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.

Bo Qiu, MD contact

+86-020-87343031

qiubo@sysucc.org.cn

DaQuan Wang, MD contact

+86-020-87343031

wangdq@sysucc.org.cn

Hui Liu principal investigator

Sun Yat-sen University

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 Neoadjuvant chemo-immunotherapy, Bevacizumab and Radiotherapy in people with Stage III Non-small Cell Lung Cancer, run by Sun Yat-sen University 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 41 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 30 Oct 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?

Results are not available in the source record.

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

Contact Bo Qiu, MD (+86-020-87343031, qiubo@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 2-year). 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 NCT05468242, which also lists 7 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 30 Oct 2024.