Non-small Cell Lung CancerPhase 3NCT04980716

Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients

A Phase 3 study testing Multiple cardiovascular drugs related to "Golden Triangle" in people with Non-small Cell Lung Cancer and Cardiovascular Complication, run by Sun Yat-sen University 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

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer, Cardiovascular Complication
What is being tested?: Multiple cardiovascular drugs related to "Golden Triangle"
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 524 participants
Where: 1 siteChina
Study dates: 1 Jun 2021to 1 Jul 2026
Phase: Phase 3
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging;
Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;
Male or female between 18 and 75 years old;
Life expectancy ≥ 12 weeks;
The World Health Organization (WHO) PS score is 0 or 1;
Organ and bone marrow function meet the following conditions: Forced expiratory volume per second (FEV1) ≥1000 ml; absolute neutrophil count ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥90 g/L ; Serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 times ULN;
A signed informed consent form is required before proceeding with any step in the research;
There is an abnormality in the initial cardiac output index.

Who cannot join

PS score 2-4;
Organ function impairment: FEV1 <1000ml; absolute neutrophil count <1.5×10^9/L; platelets <100×10^9/L; hemoglobin <90 g/ L; Serum creatinine clearance calculated according to Cockcroft-Gault formula <50 mL/min; serum bilirubin>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase>2.5 times ULN;
Unstable angina or myocardial infarction occurred in the past month;
Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
Active endocarditis;
Symptomatic severe aortic stenosis;

Show all 15Show fewer

Heart failure that has not been controlled;
Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;
Suspected or confirmed aortic dissection;
Uncontrolled bronchial asthma;
Pulmonary edema;
Fingertip blood oxygen saturation at rest ≤85%;
Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise;
Mental disorders make it impossible to cooperate.
Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.

Trial locations and contacts

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

Bo Qiu contact

+862087343031

qiubo@sysucc.org.cn

China1 site, 1 recruiting

Sun yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Bo Qiu, Professor, +862087343031
Recruiting

Other trials in China

About this study

Official title: Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients Who Receiving Radical Concurrent Chemoradiotherapy and Immunotherapy: a Prospective, Randomized Controlled, Multicenter Phase III Clinical Trial.

Read the detailed description

This is a prospective, randomized, controlled, multi-center phase III clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy. The participants were 1:1 randomized to the intervention group and the control group. The intervention group will receive cardiovascular evaluation and intervention at multiple timepoints throughout treatment and follow-up, while the control group will be under observation unless severe cardiovascular events happen.

The evaluation and intervention timepoints include: Before neoadjuvant therapy, before radiotherapy, Mid-radiotherapy, 2 months after the completion of radiotherapy, every 6 months thereafter for up to 2 years post-radiotherapy.

Conditions: Non-small Cell Lung Cancer, Cardiovascular Complication
Being tested: Multiple cardiovascular drugs related to "Golden Triangle"
Keywords: Non-small Cell Lung Cancer, Cardiovascular Intervention, Impedance Cardiography, Cardiovascular Event
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.

Multiple cardiovascular drugs related to "Golden Triangle"Drug
Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.

Study groups in NCT04980716
Study group	Role	What they receive
The early intervention group	Experimental	The early intervention group: evaluation and intervention based on impedance cardiography results at multiple timepoints. Specific intervention measures include: 1. cardiovascular drug treatment: based on the increase and decrease of the "Golden Triangle" 1. ACEI, perindopril tert-butyrate 4mg qd 2. β receptor antagonist, metoprolol succinate 47.5mg qd 3. Spironolactone 20mg qd 4. Drugs to improve myocardial metabolism: trimetazidine hydrochloride 35 mg bid 5. Other therapeutic drugs include: loop diuretics, ARNI, sinus node If current selection specific inhibitors, statins, antiplatelet aggregation and nitrate drugs, etc. 2. Exercise intervention: exercise prescription based on the initial cardiopulmonary exercise test results. Receives: Drug: Multiple cardiovascular drugs related to "Golden Triangle"
The control group	No intervention	This group will be under observation. When cardiovascular events (including ischemic cardiomyopathy, heart failure, arrhythmia requiring treatment, pericardial disease requiring treatment, valvular disease, etc.) happen, a cardiovascular specialist assessment and intervention will be given.

What is being measured

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

Overall survival
It was calculated from the first day of treatment to the day of death.
Measured: 2-year
The incidence of grade 2+ cardiotoxicity events
Culmulative incidence of grade 2+ cardiotoxicity events
Measured: 2-year

Secondary outcomes (2)

Progression-free survival
From the first day of treatment to the day of progression or the day of death.
Measured: 2-year
The incidence of grade 2+ pulmonary toxicity
Culmulative incidence of grade 2+ pulmonary toxicity
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 Jun 20211 Jul 2026

First posted28 Jul 2021
Study start1 Jun 2021
Primary completion31 Jan 2026 (estimated)
Study completion1 Jul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 524 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04980716
Sponsor's protocol ID: GASTO-1074
Status last verified: Nov 2025
First submitted: 24 Jul 2021
Last updated: 18 Nov 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593
Wang H, Wei J, Zheng Q, Meng L, Xin Y, Yin X, Jiang X. Radiation-induced heart disease: a review of classification, mechanism and prevention. Int J Biol Sci. 2019 Aug 8;15(10):2128-2138. doi: 10.7150/ijbs.35460. eCollection 2019.
PubMed 31592122
Beukema JC, van Luijk P, Widder J, Langendijk JA, Muijs CT. Is cardiac toxicity a relevant issue in the radiation treatment of esophageal cancer? Radiother Oncol. 2015 Jan;114(1):85-90. doi: 10.1016/j.radonc.2014.11.037. Epub 2014 Dec 30.
PubMed 25554226
Dess RT, Sun Y, Matuszak MM, Sun G, Soni PD, Bazzi L, Murthy VL, Hearn JWD, Kong FM, Kalemkerian GP, Hayman JA, Ten Haken RK, Lawrence TS, Schipper MJ, Jolly S. Cardiac Events After Radiation Therapy: Combined Analysis of Prospective Multicenter Trials for Locally Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2017 May 1;35(13):1395-1402. doi: 10.1200/JCO.2016.71.6142. Epub 2017 Mar 16.
PubMed 28301264
Atkins KM, Rawal B, Chaunzwa TL, Lamba N, Bitterman DS, Williams CL, Kozono DE, Baldini EH, Chen AB, Nguyen PL, D'Amico AV, Nohria A, Hoffmann U, Aerts HJWL, Mak RH. Cardiac Radiation Dose, Cardiac Disease, and Mortality in Patients With Lung Cancer. J Am Coll Cardiol. 2019 Jun 18;73(23):2976-2987. doi: 10.1016/j.jacc.2019.03.500.
PubMed 31196455
Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.
PubMed 25601342
Wang K, Eblan MJ, Deal AM, Lipner M, Zagar TM, Wang Y, Mavroidis P, Lee CB, Jensen BC, Rosenman JG, Socinski MA, Stinchcombe TE, Marks LB. Cardiac Toxicity After Radiotherapy for Stage III Non-Small-Cell Lung Cancer: Pooled Analysis of Dose-Escalation Trials Delivering 70 to 90 Gy. J Clin Oncol. 2017 May 1;35(13):1387-1394. doi: 10.1200/JCO.2016.70.0229. Epub 2017 Jan 23.
PubMed 28113017
Boekel NB, Schaapveld M, Gietema JA, Russell NS, Poortmans P, Theuws JC, Schinagl DA, Rietveld DH, Versteegh MI, Visser O, Rutgers EJ, Aleman BM, van Leeuwen FE. Cardiovascular Disease Risk in a Large, Population-Based Cohort of Breast Cancer Survivors. Int J Radiat Oncol Biol Phys. 2016 Apr 1;94(5):1061-72. doi: 10.1016/j.ijrobp.2015.11.040. Epub 2015 Dec 14.
PubMed 27026313
Boero IJ, Paravati AJ, Triplett DP, Hwang L, Matsuno RK, Gillespie EF, Yashar CM, Moiseenko V, Einck JP, Mell LK, Parikh SA, Murphy JD. Modern Radiation Therapy and Cardiac Outcomes in Breast Cancer. Int J Radiat Oncol Biol Phys. 2016 Mar 15;94(4):700-8. doi: 10.1016/j.ijrobp.2015.12.018. Epub 2015 Dec 17.
PubMed 26972642
Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Balint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.
PubMed 26045340
Fossella FV, Lee JS, Murphy WK, Lippman SM, Calayag M, Pang A, Chasen M, Shin DM, Glisson B, Benner S, et al. Phase II study of docetaxel for recurrent or metastatic non-small-cell lung cancer. J Clin Oncol. 1994 Jun;12(6):1238-44. doi: 10.1200/JCO.1994.12.6.1238.
PubMed 7911160
Kido H, Morizane C, Tamura T, Hagihara A, Kondo S, Ueno H, Okusaka T. Gemcitabine-induced pleuropericardial effusion in a patient with pancreatic cancer. Jpn J Clin Oncol. 2012 Sep;42(9):845-50. doi: 10.1093/jjco/hys099. Epub 2012 Jul 10.
PubMed 22782959
Eremina V, Jefferson JA, Kowalewska J, Hochster H, Haas M, Weisstuch J, Richardson C, Kopp JB, Kabir MG, Backx PH, Gerber HP, Ferrara N, Barisoni L, Alpers CE, Quaggin SE. VEGF inhibition and renal thrombotic microangiopathy. N Engl J Med. 2008 Mar 13;358(11):1129-36. doi: 10.1056/NEJMoa0707330.
PubMed 18337603
Wang J, Okazaki IM, Yoshida T, Chikuma S, Kato Y, Nakaki F, Hiai H, Honjo T, Okazaki T. PD-1 deficiency results in the development of fatal myocarditis in MRL mice. Int Immunol. 2010 Jun;22(6):443-52. doi: 10.1093/intimm/dxq026. Epub 2010 Apr 21.
PubMed 20410257
Heinzerling L, Ott PA, Hodi FS, Husain AN, Tajmir-Riahi A, Tawbi H, Pauschinger M, Gajewski TF, Lipson EJ, Luke JJ. Cardiotoxicity associated with CTLA4 and PD1 blocking immunotherapy. J Immunother Cancer. 2016 Aug 16;4:50. doi: 10.1186/s40425-016-0152-y. eCollection 2016.
PubMed 27532025

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients Who Receiving Radical Concurrent Chemoradiotherapy and Immunotherapy: a Prospective, Randomized Controlled, Multicenter Phase III Clinical Trial.
ClinicalTrials.gov ID: NCT04980716
Acronym / sponsor ID: GASTO-1074
Conditions: Non-small Cell Lung Cancer, Cardiovascular Complication
Keywords: Non-small Cell Lung Cancer, Cardiovascular Intervention, Impedance Cardiography, Cardiovascular Event
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 524 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 1 Jun 2021 (actual)
Primary completion: 31 Jan 2026 (estimated)
Study completion: 1 Jul 2026 (estimated)
First posted: 28 Jul 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
The early intervention group	Experimental	Drug: Multiple cardiovascular drugs related to "Golden Triangle"The early intervention group: evaluation and intervention based on impedance cardiography results at multiple timepoints. Specific intervention measures include: 1. cardiovascular drug treatment: based on the increase and decrease of the "Golden Triangle" 1. ACEI, perindopril tert-butyrate 4mg qd 2. β receptor antagonist, metoprolol succinate 47.5mg qd 3. Spironolactone 20mg qd 4. Drugs to improve myocardial metabolism: trimetazidine hydrochloride 35 mg bid 5. Other therapeutic drugs include: loop diuretics, ARNI, sinus node If current selection specific inhibitors, statins, antiplatelet aggregation and nitrate drugs, etc. 2. Exercise intervention: exercise prescription based on the initial cardiopulmonary exercise test results.
The control group	No intervention	–This group will be under observation. When cardiovascular events (including ischemic cardiomyopathy, heart failure, arrhythmia requiring treatment, pericardial disease requiring treatment, valvular disease, etc.) happen, a cardiovascular specialist assessment and intervention will be given.

Who may qualify

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

Key inclusion criteria (8 listed)

It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging;
Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;
Male or female between 18 and 75 years old;
Life expectancy ≥ 12 weeks;
The World Health Organization (WHO) PS score is 0 or 1;

Key exclusion criteria (15 listed)

PS score 2-4;
Organ function impairment: FEV1 <1000ml; absolute neutrophil count <1.5×10^9/L; platelets <100×10^9/L; hemoglobin <90 g/ L; Serum creatinine clearance calculated according to Cockcroft-Gault formula <50 mL/min; serum bilirubin>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase>2.5 times ULN;
Unstable angina or myocardial infarction occurred in the past month;
Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
Active endocarditis;

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
Multiple cardiovascular drugs related to "Golden Triangle"Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.	Drug	The early intervention group

Primary outcome

Overall survival
Time frame: 2-year
It was calculated from the first day of treatment to the day of death.
The incidence of grade 2+ cardiotoxicity events
Time frame: 2-year
Culmulative incidence of grade 2+ cardiotoxicity events

2 secondary outcomes

Progression-free survival
Time frame: 2-year
The incidence of grade 2+ pulmonary toxicity
Time frame: 2-year

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 18 Nov 2025.
Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
Background: PubMed 31592122Wang H, Wei J, Zheng Q, Meng L, Xin Y, Yin X, Jiang X. Radiation-induced heart disease: a review of classification, mechanism and prevention. Int J Biol Sci. 2019 Aug 8;15(10):2128-2138. doi: 10.7150/ijbs.35460. eCollection 2019.
Background: PubMed 25554226Beukema JC, van Luijk P, Widder J, Langendijk JA, Muijs CT. Is cardiac toxicity a relevant issue in the radiation treatment of esophageal cancer? Radiother Oncol. 2015 Jan;114(1):85-90. doi: 10.1016/j.radonc.2014.11.037. Epub 2014 Dec 30.
Background: PubMed 28301264Dess RT, Sun Y, Matuszak MM, Sun G, Soni PD, Bazzi L, Murthy VL, Hearn JWD, Kong FM, Kalemkerian GP, Hayman JA, Ten Haken RK, Lawrence TS, Schipper MJ, Jolly S. Cardiac Events After Radiation Therapy: Combined Analysis of Prospective Multicenter Trials for Locally Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2017 May 1;35(13):1395-1402. doi: 10.1200/JCO.2016.71.6142. Epub 2017 Mar 16.
Background: PubMed 31196455Atkins KM, Rawal B, Chaunzwa TL, Lamba N, Bitterman DS, Williams CL, Kozono DE, Baldini EH, Chen AB, Nguyen PL, D'Amico AV, Nohria A, Hoffmann U, Aerts HJWL, Mak RH. Cardiac Radiation Dose, Cardiac Disease, and Mortality in Patients With Lung Cancer. J Am Coll Cardiol. 2019 Jun 18;73(23):2976-2987. doi: 10.1016/j.jacc.2019.03.500.
Background: PubMed 25601342Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.
Background: PubMed 28113017Wang K, Eblan MJ, Deal AM, Lipner M, Zagar TM, Wang Y, Mavroidis P, Lee CB, Jensen BC, Rosenman JG, Socinski MA, Stinchcombe TE, Marks LB. Cardiac Toxicity After Radiotherapy for Stage III Non-Small-Cell Lung Cancer: Pooled Analysis of Dose-Escalation Trials Delivering 70 to 90 Gy. J Clin Oncol. 2017 May 1;35(13):1387-1394. doi: 10.1200/JCO.2016.70.0229. Epub 2017 Jan 23.
Background: PubMed 27026313Boekel NB, Schaapveld M, Gietema JA, Russell NS, Poortmans P, Theuws JC, Schinagl DA, Rietveld DH, Versteegh MI, Visser O, Rutgers EJ, Aleman BM, van Leeuwen FE. Cardiovascular Disease Risk in a Large, Population-Based Cohort of Breast Cancer Survivors. Int J Radiat Oncol Biol Phys. 2016 Apr 1;94(5):1061-72. doi: 10.1016/j.ijrobp.2015.11.040. Epub 2015 Dec 14.
Background: PubMed 26972642Boero IJ, Paravati AJ, Triplett DP, Hwang L, Matsuno RK, Gillespie EF, Yashar CM, Moiseenko V, Einck JP, Mell LK, Parikh SA, Murphy JD. Modern Radiation Therapy and Cardiac Outcomes in Breast Cancer. Int J Radiat Oncol Biol Phys. 2016 Mar 15;94(4):700-8. doi: 10.1016/j.ijrobp.2015.12.018. Epub 2015 Dec 17.
Background: PubMed 26045340Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Balint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.
Background: PubMed 7911160Fossella FV, Lee JS, Murphy WK, Lippman SM, Calayag M, Pang A, Chasen M, Shin DM, Glisson B, Benner S, et al. Phase II study of docetaxel for recurrent or metastatic non-small-cell lung cancer. J Clin Oncol. 1994 Jun;12(6):1238-44. doi: 10.1200/JCO.1994.12.6.1238.
Background: PubMed 22782959Kido H, Morizane C, Tamura T, Hagihara A, Kondo S, Ueno H, Okusaka T. Gemcitabine-induced pleuropericardial effusion in a patient with pancreatic cancer. Jpn J Clin Oncol. 2012 Sep;42(9):845-50. doi: 10.1093/jjco/hys099. Epub 2012 Jul 10.

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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.

Bo Qiu contact

+862087343031

qiubo@sysucc.org.cn

Hui Liu, Professor principal investigator

Sun yat-sen universtiy cancer center

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 8 inclusion and 15 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 18 Nov 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Bo Qiu (+862087343031, qiubo@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 2-year). 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 NCT04980716, which also lists 25 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 18 Nov 2025.