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Locally Advanced Non-small Cell Lung CancerPhase 2NCT05481775

Evaluating Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer

A Phase 2 study testing Anlotinib, Chemotherapy and Radiotherapy in people with Locally Advanced Non-small Cell Lung Cancer and Efficacy and Safety, run by Sun Yat-sen University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a prospective, randomized, controlled phase II clinical study for evaluating anlotinib combined with concurrent chemoradiotherapy followed by consolidation immunotherapy versus concurrent chemoradiotherapy followed by consolidation immunotherapy in locally advanced, unresectable NSCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Anlotinib, Chemotherapy and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
1 Apr 2022to 30 Sep 2025
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

  • informed consent is required before proceeding with any steps in the study;
  • Male or female 18-75 years old;
  • Patients must be locally advanced, unresectable (stage IIIA-IIIC) with histology reported NSCLC (except for central squamous cell carcinoma or those at risk for massive hemoptysis);
  • No prior chemotherapy, immunotherapy, radiotherapy, surgery, or targeted therapy;
  • Tumor sample requirements: must provide sufficient evidence to allow analysis Stained, archived tumor tissue samples;
  • Life expectancy ≥ 12 weeks;
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  • World Health Organization (WHO) PS score of 0 or 1;
  • Postmenopausal women, or negative urine or serum pregnancy test (HCG) within 14 days prior to study drug administration
  • Women of childbearing potential (WOCBP) must agree to adhere to contraceptive methods during study drug treatment and for 6 months after the last study drug treatment;
  • Men who have sex with WOCBP must agree to adhere to contraception during study drug treatment and for 6 months after the last study drug treatment;
  • azoospermic men do not have to adhere to contraceptive requirements. Adolescents of childbearing potential without heterosexual sex (WOCBP) do not have to comply with contraceptive requirements, but must still undergo a pregnancy test as described in this section;
  • Organ and bone marrow function meet the following conditions: Forced expiratory volume in 1 second (FEV1) ≥ 800ml; Absolute neutrophil count ≥1.5×10^9/L; Platelet ≥100×10^9/L; Hemoglobin ≥9.0g/dL; Serum creatinine clearance calculated according to Cockcroft-Gault formula ≥50 mL/ min (Cockcroft and Gault 1976); Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN.

Who cannot join

  • Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study;
  • Histological type of small cell lung cancer (including mixed small cell and non-small cell lung cancer);
  • Prior use of any targeted therapy;
  • The central cavity squamous cell carcinoma or non-small cell lung cancer with hemoptysis (the amount of hemoptysis> 50 ml/d);
  • The patient has conditions that affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction, etc.) ;
  • Major surgery (excluding vascular access) within 4 weeks prior to study entry;
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  • Heart rate-corrected mean QT interval (QTc) ≥ 470 ms, calculated from 3 electrocardiogram calculation cycles (ECG) using Bazett correction;
  • No Controlled complications, including but not limited to persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active hemorrhagic Illness, including any known HBsAg-positive patient with HBV DNA > 500 IU/ml, Hepatitis C or Human Immunodeficiency Virus (HIV), or mental illness that would limit compliance with study requirements or impair the patient's ability to give written informed consent/ Social status;
  • History of another primary malignancy within 5 years prior to initiation of therapy, excluding adequately treated skin basal or squamous cell carcinoma or cervical carcinoma in situ;
  • Pregnant, breastfeeding women; Contraceptive method, male or female of reproductive potential; - Conditions that may interfere with the evaluation of the efficacy or safety of the treatment.
  • Patients who progressed after concurrent chemoradiotherapy;
  • History of tuberculosis, excluding old pulmonary tuberculosis;
  • Received live attenuated vaccine within 30 days before study initiation or within 30 days after tislelizide;
  • In Use of immunosuppressive drugs within 28 days prior to the first dose of tislelizumab. Of these, intranasal inhaled corticosteroids at physiological doses are excluded; prednisone or an equivalent amount of systemic corticosteroids not exceeding 10 mg per day is excluded. Steroids are permitted for management of chemoradiotherapy-related toxicity;
  • Patients with unrecovered CTCAE > 2 toxicity after prior targeted combination chemoradiotherapy will be excluded from randomization;
  • due to prior targeted combined chemoradiotherapy, patients with grade ≥2 pneumonitis undergoing chemotherapy will be excluded from randomization.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Evaluating Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy Versus Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer: A Prospective, Randomized Controlled Phase II Clinical Trial

This is a prospective, randomized, controlled phase II clinical study for evaluating anlotinib combined with concurrent chemoradiotherapy followed by consolidation immunotherapy versus concurrent chemoradiotherapy followed by consolidation immunotherapy in locally advanced, unresectable NSCLC.

Read the detailed description

This is a prospective, randomized, controlled phase II clinical study for evaluating anlotinib combined with concurrent chemoradiotherapy followed by consolidation immunotherapy versus concurrent chemoradiotherapy followed by consolidation immunotherapy in locally advanced, unresectable NSCLC. In this study, the enrolled patients were divided into the experimental group and the control group at a ratio of 1:1. The patients in the experimental group received anlotinib combined with curative concurrent chemoradiotherapy first, while the patients in the control group received curative concurrent chemoradiotherapy. Those who are evaluated as CR, PR or SD after the aforementioned treatment will enter consolidation immunotherapy. Patients will receive tislelizumab 200mg iv. drip, Q3W, for up to 12 months.

Being tested
Anlotinib, Chemotherapy, Radiotherapy, Immunotherapy
Keywords
Locally advanced non-small cell lung cancer, Anlotinib combined with chemoradiotherapy, Consolidation immunotherapy

What participants receive

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

  • AnlotinibDrug

    Anlotinib 8mg qd po. Taking anlotinib daily for 2 weeks and stop for 1 week.

  • ChemotherapyDrug

    Also called Concurrent chemoradiotherapy

    Docetaxel 25mg/m2 + Cisplatin 25mg/m2 QW

  • RadiotherapyRadiation

    Also called Concurrent chemoradiotherapy

    Thoracic radiotherapy was delivered using the daily image-guided intensity modulated radiation therapy (IMRT) technique. The total radiation dose was 66-68 Gy to the gross tumor in 17-22 daily fractions.

  • ImmunotherapyDrug

    consolidation Immunotherapy (Tislelizhu 200mg iv. drip, Q3W, up to 12 months.)

Study groups in NCT05481775
Study groupRoleWhat they receive
Experiment groupExperimentalAnlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy
Receives: Drug: Anlotinib; Drug: Chemotherapy; Radiation: Radiotherapy; Drug: Immunotherapy
Control groupActive comparatorConcurrent Chemoradiotherapy Followed by Consolidation Immunotherapy
Receives: Drug: Chemotherapy; Radiation: Radiotherapy; Drug: Immunotherapy

What is being measured

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

  1. 18-months progression-free survival rate

    From the first day of treatment to the day of progression or the day of death.

    Measured: 18-months

Secondary outcomes (4)

  1. Overall survival

    It was calculated from the first day of treatment to the day of death.

    Measured: 18-months

  2. objective response rate

    The proportion patients evaluated for CR and PR

    Measured: 18-months

  3. Incidence of Treatment-related Adverse Events

    Adverse effects are graded according to the CTCAE 5.0 version, including multiple organs and tissues, such as gastrointestinal disease and symptom, cardiovascular disease, respiratory diseases and so on.

    Measured: 18 months after therapy

  4. Score of EORTC QLQ-C30

    The evaluation of life quality

    Measured: 18 months after therapy

Timeline

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

  1. First posted1 Aug 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Why it stopped: Clincal decision based on previous results

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481775
Sponsor's protocol ID
GASTO-1088
Status last verified
Nov 2022
First submitted
4 Jul 2022
Last updated
21 Nov 2022
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

  • Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Ozguroglu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19.

    PubMed 33476803

  • Lin B, Song X, Yang D, Bai D, Yao Y, Lu N. Anlotinib inhibits angiogenesis via suppressing the activation of VEGFR2, PDGFRbeta and FGFR1. Gene. 2018 May 15;654:77-86. doi: 10.1016/j.gene.2018.02.026. Epub 2018 Feb 14.

    PubMed 29454091

  • Palakurthi S, Kuraguchi M, Zacharek SJ, Zudaire E, Huang W, Bonal DM, Liu J, Dhaneshwar A, DePeaux K, Gowaski MR, Bailey D, Regan SN, Ivanova E, Ferrante C, English JM, Khosla A, Beck AH, Rytlewski JA, Sanders C, Laquerre S, Bittinger MA, Kirschmeier PT, Packman K, Janne PA, Moy C, Wong KK, Verona RI, Lorenzi MV. The Combined Effect of FGFR Inhibition and PD-1 Blockade Promotes Tumor-Intrinsic Induction of Antitumor Immunity. Cancer Immunol Res. 2019 Sep;7(9):1457-1471. doi: 10.1158/2326-6066.CIR-18-0595. Epub 2019 Jul 22.

    PubMed 31331945

  • Yang Y, Li L, Jiang Z, Wang B, Pan Z. Anlotinib optimizes anti-tumor innate immunity to potentiate the therapeutic effect of PD-1 blockade in lung cancer. Cancer Immunol Immunother. 2020 Dec;69(12):2523-2532. doi: 10.1007/s00262-020-02641-5. Epub 2020 Jun 23.

    PubMed 32577817

  • Liu S, Qin T, Liu Z, Wang J, Jia Y, Feng Y, Gao Y, Li K. anlotinib alters tumor immune microenvironment by downregulating PD-L1 expression on vascular endothelial cells. Cell Death Dis. 2020 May 4;11(5):309. doi: 10.1038/s41419-020-2511-3.

    PubMed 32366856

  • Guo L, Zhang L, Guan Y, Li Y, Zhang C, Guo Q. In vitro studies of H520 cell cycle and apoptosis by anlotinib combined with radiotherapy. Thorac Cancer. 2021 Mar;12(5):593-602. doi: 10.1111/1759-7714.13780. Epub 2021 Jan 12.

    PubMed 33438349

  • He Z, Liu J, Ma Y, Jiang H, Cui Z, Wang G, Wu Y, Liu J, Cai X, Qian J, Huang J, Zhang H, Li H. Anlotinib Combined with Cranial Radiotherapy for Non-Small Cell Lung Cancer Patients with Brain Metastasis: A Retrospectively, Control Study. Cancer Manag Res. 2021 Aug 4;13:6101-6111. doi: 10.2147/CMAR.S319650. eCollection 2021.

    PubMed 34377028

  • Zhuang H, Wang Y, Cheng C, Shi S. The efficacy of anlotinib instead of glucocorticoids for edema induced by brain metastases in NSCLC patients with anti-PD1/PDL-1 immunotherapy. Neuro Oncol. 2021 Jan 30;23(1):169-171. doi: 10.1093/neuonc/noaa236. No abstract available.

    PubMed 33294918

  • Wang Y, Deng W, Li N, Neri S, Sharma A, Jiang W, Lin SH. Combining Immunotherapy and Radiotherapy for Cancer Treatment: Current Challenges and Future Directions. Front Pharmacol. 2018 Mar 5;9:185. doi: 10.3389/fphar.2018.00185. eCollection 2018.

    PubMed 29556198

  • Liao ZX, Komaki RR, Thames HD Jr, Liu HH, Tucker SL, Mohan R, Martel MK, Wei X, Yang K, Kim ES, Blumenschein G, Hong WK, Cox JD. Influence of technologic advances on outcomes in patients with unresectable, locally advanced non-small-cell lung cancer receiving concomitant chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):775-81. doi: 10.1016/j.ijrobp.2009.02.032. Epub 2009 Jun 8.

    PubMed 19515503

  • 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

  • Franceschini D, Paiar F, Meattini I, Agresti B, Pasquetti EM, Greto D, Bonomo P, Marrazzo L, Casati M, Livi L, Biti G. Simultaneous integrated boost-intensity-modulated radiotherapy in head and neck cancer. Laryngoscope. 2013 Dec;123(12):E97-103. doi: 10.1002/lary.24257. Epub 2013 Jun 26.

    PubMed 23775348

  • Wu B, McNutt T, Zahurak M, Simari P, Pang D, Taylor R, Sanguineti G. Fully automated simultaneous integrated boosted-intensity modulated radiation therapy treatment planning is feasible for head-and-neck cancer: a prospective clinical study. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):e647-53. doi: 10.1016/j.ijrobp.2012.06.047. Epub 2012 Aug 3.

    PubMed 22867890

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib, Chemotherapy and Radiotherapy in people with Locally Advanced Non-small Cell Lung Cancer and Efficacy and Safety, 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 12 inclusion and 16 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: withdrawn, as of the sponsor's last update on 21 Nov 2022. 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

18-months progression-free survival rate (time frame: 18-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 NCT05481775, which also lists 14 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 21 Nov 2022.

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