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Locally Advanced Non-Small Cell Lung CancerPhase 2NCT07037680

Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT

A Phase 2 study testing Anlotinib in people with Locally Advanced Non-Small Cell Lung Cancer and Thoracic Radiotherapy, run by JIANYANG WANG at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Anlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
1 Jan 2024to 30 Jun 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years old with no restrictions on sex;
  • Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma;
  • Eastern cooperative oncology group (ECOG) score ≤2 was required;
  • Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression;
  • .No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk;
  • No symptoms of hemoptysis;
  • Adequate hepatic and renal functions with a negative urine protein;
  • Expected survival of more than 6 months.

Who cannot join

  • currently receiving treatment for malignancies at other sites, except for curable non-melanoma skin cancer and cervical carcinoma in situ;
  • previous malignancy within five years;
  • thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months;
  • uncontrolled or active pulmonary inflammation;
  • participated in other clinical trials;
  • Pregnant women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Radiation Oncology,Cancer Institute and Hospital,Chinese

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: Efficiency and Safety of Radiotherapy Combined With Anlotinib in Locally Advanced Non-small Cell Lung Cancer Patients Intolerable to Concurrent Chemoradiotherapy: A Phase II Single-arm Trial

Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.

Being tested
Anlotinib
Keywords
thoracic radiotherapy, non-small cell lung carcinoma, locally advanced, safety, Anlotinib
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.

  • AnlotinibDrug

    For patients treated with conventional Intensity-Modulated Radiation Therapy (IMRT), the median prescribed dose was 60 Gy/30 fractions (range: 50.0-70.0 Gy, in 25-35 fractions) (median BED10 72 Gy, range: 60-84 Gy) to the planning target volume (PTV). As for patients with IMRT-based simultaneously integrated boost (SIB), the median prescribed dose was 59.92 Gy/28 fractions (range: 50.0-70.0 Gy, in 25-33 fractions) (median BED10 72.74 Gy, range: 60-84 Gy) to the planning gross tumor volume (PGTV), and 50.4 Gy/28 fractions (range: 45-59.4 Gy, in 25-33 fractions) (median BED10 59.47 Gy, range: 53.1-70.1 Gy) to the PTV. It should be noted that the PTV in the SIB group contains the PGTV.

    Anlotinib was administered orally concurrently with the first day of radiotherapy, at a dose of 12 mg for a maximum of three cycles. Each cycle was defined as 2 weeks on-treatment followed by 1 week off-treatment. If intolerance occurs, the dose may be reduced to 8-10 mg/day or stopped.

Study groups in NCT07037680
Study groupRoleWhat they receive
Radiotherapy plus AnlotinibExperimentalRadiotherapy plus anlotinib in LA-NSCLC intolerable to cCRT
Receives: Drug: Anlotinib

What is being measured

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

  1. 2-year progression-free survival (PFS)

    Measured: From the first day of radiotherapy to the occurrence of objective tumor progression or death due to any cause, whichever occurs first, assessed up to 60 months

Secondary outcomes (4)

  1. Overall Survival(OS)

    Measured: From the first day of radiotherapy to the occurrence of death due to any cause, assessed up to 60 months

  2. Local regional recurrence (LR)

    Measured: From the first day of radiotherapy to the occurrence of clinical and/or biopsy-proven recurrence within the bronchial stump, ipsilateral hilum, mediastinum, or supraclavicular, whichever occurs first, assessed up to 60 months

  3. Distant metastasis (DM)

    Measured: From the first day of radiotherapy to the occurrence of any evidence of metastatic disease beyond the locoregional regions previously mentioned, assessed up to 60 months

  4. Acute toxicity

    Measured: From the first day of radiotherapy and up to the 3-month post-radiotherapy follow-up visit

Timeline

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

  1. First posted25 Jun 2025
  2. Study start1 Jan 2024
  3. Primary completion1 Jun 2026
  4. Study completion30 Jun 2026

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
Not applicable
Intervention model
Single group
Model description
A phase II randomized trial (registered in Clinical Trials.gov as NCT05888402) of unresectable stage III NSCLC patients undergone definitive concurrent chemoradiotherapy was prespecified to compare the 2-year PFS difference with that of current trial.
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037680
Sponsor's protocol ID
NCC2827
Status last verified
Oct 2026
First submitted
28 May 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

    PubMed 2702835

  • Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM, Pollock T, Levchenko E, Reguart N, Martinez-Marti A, Houghton B, Paoli JB, Safina S, Park K, Komiya T, Sanford A, Boolell V, Liu H, Samkari A, Keller SM, Reck M. Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. JAMA Oncol. 2021 Jun 4;7(9):1-9. doi: 10.1001/jamaoncol.2021.2301. Online ahead of print.

    PubMed 34086039

  • Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata 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, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

    PubMed 30280658

  • Zhou Q, Chen M, Jiang O, Pan Y, Hu D, Lin Q, Wu G, Cui J, Chang J, Cheng Y, Huang C, Liu A, Yang N, Gong Y, Zhu C, Ma Z, Fang J, Chen G, Zhao J, Shi A, Lin Y, Li G, Liu Y, Wang D, Wu R, Xu X, Shi J, Liu Z, Cui N, Wang J, Wang Q, Zhang R, Yang J, Wu YL. Sugemalimab versus placebo after concurrent or sequential chemoradiotherapy in patients with locally advanced, unresectable, stage III non-small-cell lung cancer in China (GEMSTONE-301): interim results of a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):209-219. doi: 10.1016/S1470-2045(21)00630-6. Epub 2022 Jan 14.

    PubMed 35038429

  • Garassino MC, Mazieres J, Reck M, Chouaid C, Bischoff H, Reinmuth N, Cove-Smith L, Mansy T, Cortinovis D, Migliorino MR, Delmonte A, Sanchez JG, Chara Velarde LE, Bernabe R, Paz-Ares L, Perez ID, Trunova N, Foroutanpour K, Faivre-Finn C. Durvalumab After Sequential Chemoradiotherapy in Stage III, Unresectable NSCLC: The Phase 2 PACIFIC-6 Trial. J Thorac Oncol. 2022 Dec;17(12):1415-1427. doi: 10.1016/j.jtho.2022.07.1148. Epub 2022 Aug 9.

    PubMed 35961520

  • Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.

    PubMed 7713792

  • Han B, Li K, Wang Q, Zhang L, Shi J, Wang Z, Cheng Y, He J, Shi Y, Zhao Y, Yu H, Zhao Y, Chen W, Luo Y, Wu L, Wang X, Pirker R, Nan K, Jin F, Dong J, Li B, Sun Y. Effect of Anlotinib as a Third-Line or Further Treatment on Overall Survival of Patients With Advanced Non-Small Cell Lung Cancer: The ALTER 0303 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2018 Nov 1;4(11):1569-1575. doi: 10.1001/jamaoncol.2018.3039.

    PubMed 30098152

  • Wang D, Bi N, Zhang T, Zhou Z, Xiao Z, Liang J, Chen D, Hui Z, Lv J, Wang X, Wang X, Deng L, Wang W, Wang J, Wang C, Lu X, Xu K, Wu L, Xue W, Feng Q, Wang L. Comparison of efficacy and safety between simultaneous integrated boost intensity-modulated radiotherapy and conventional intensity-modulated radiotherapy in locally advanced non-small-cell lung cancer: a retrospective study. Radiat Oncol. 2019 Jun 13;14(1):106. doi: 10.1186/s13014-019-1259-3.

    PubMed 31196118

  • Sun P, Li Y, Li C, Ren K, Wang Y, Yang H, Jiang W, Zou L, Yang H, Zhou H, Li ZM. A phase II study of sintilimab, anlotinib, and pegaspargase sandwiched with radiotherapy as first-line therapy in patients with newly diagnosed, stage I-II extranodal natural-killer/T-cell lymphoma. Am J Hematol. 2023 Jul;98(7):1043-1051. doi: 10.1002/ajh.26922. Epub 2023 Apr 7.

    PubMed 36970971

  • Li PJ, Lai SZ, Jin T, Ying HJ, Chen YM, Zhang P, Hang QQ, Deng H, Wang L, Feng JG, Chen XZ, Guo P, Chen M, Tian Y, Chen YY. Radiotherapy opens the blood-brain barrier and synergizes with anlotinib in treating glioblastoma. Radiother Oncol. 2023 Jun;183:109633. doi: 10.1016/j.radonc.2023.109633. Epub 2023 Mar 23.

    PubMed 36963438

  • 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

  • Wozniak AJ, Moon J, Thomas CR Jr, Kelly K, Mack PC, Gaspar LE, Raben D, Fitzgerald TJ, Pandya KJ, Gandara DR. A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Combination of Bevacizumab (NSC-704865) in Patients With Inoperable Locally Advanced Stage III Non-Small-Cell Lung Cancer: SWOG S0533. Clin Lung Cancer. 2015 Sep;16(5):340-7. doi: 10.1016/j.cllc.2014.12.014. Epub 2015 Jan 9.

    PubMed 25703100

  • Lind JS, Senan S, Smit EF. Pulmonary toxicity after bevacizumab and concurrent thoracic radiotherapy observed in a phase I study for inoperable stage III non-small-cell lung cancer. J Clin Oncol. 2012 Mar 10;30(8):e104-8. doi: 10.1200/JCO.2011.38.4552. Epub 2012 Feb 13. No abstract available.

    PubMed 22331948

  • Spigel DR, Hainsworth JD, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol. 2010 Jan 1;28(1):43-8. doi: 10.1200/JCO.2009.24.7353. Epub 2009 Nov 9.

    PubMed 19901100

  • Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.

    PubMed 20351327

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib in people with Locally Advanced Non-Small Cell Lung Cancer and Thoracic Radiotherapy, run by JIANYANG WANG 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 7 Oct 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

2-year progression-free survival (PFS) (time frame: From the first day of radiotherapy to the occurrence of objective tumor progression or death due to any cause, whichever occurs first, assessed up to 60 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 NCT07037680, which also lists 17 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 7 Oct 2026.

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