A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC

NCT04636593 | Unknown Phase 2

• 1 other identifier: AlmonTRT
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Previous clinical studies showed there is a potential value of EGFR-TKI in local advanced EGFR-mutant NSCLC, while the risk of radiation pneumonia in combination of EGFR-TKI with thoracic radiotherapy is unknown. This study aims to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in local advanced EGFR-mutant NSCLC patients.

Conditions

Non Small Cell Lung Cancer; Stage III NSCLC; EGFR Activating Mutation

Keywords

radiotherapy; radiation pneumonitis; almonertinib; lung cancer; EGFR-TKI

Outcome Measures

Primary Outcomes (1)

• RP(≥3)

  incidence of radiation pneumonitis (≥ grade 3) within 6 month after Radiotherapy

  6 months

Secondary Outcomes (3)

• LCR

  1 years

• PFS

  2 years

• OS

  2 years

Study Arms (2)

Induction group

EXPERIMENTAL

If the lung V20 of initial radiation plan is equal to or more than 28%, then the patient will receive 2 months almonertinib before concurrent thoracic radiotherapy

Drug: Almonertinib

Concurrent group

EXPERIMENTAL

If the lung V20 of initial radiation plan is less than 28%, then the patient will receive concurrent thoracic radiotherapy with almonertinib.

Drug: Almonertinib

Interventions

Almonertinib DRUG

All enrolled patients underwent positioning CT scans before the initial treatment, a radiotherapy plan was made for each patient, and the lung V20 of each patient was calculated. Patients with lung V20 ≥ 28% were enrolled in group A: Almonertinib induction therapy was given for 2 months firstly, followed by Almonertinib combined with radiotherapy; patients with lung V20\<28% were enrolled in group B: Almonertinib was synchronized with radiotherapy initially.

Also known as: Thoracic Radiotherapy

Concurrent group; Induction group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed histologically or pathologically as non-small cell lung cancer;
• According to the eighth edition of the 2015 IASLC international lung cancer staging, imaging staging assessed as inoperable stage III patients (according to the eighth edition of the 2015 IASLC international lung cancer staging);
• Blood or tissue EGFR detection is Exon 19 deletion or L858R mutation;
• Have not received systemic anti-tumor therapy;
• FEV1\>0.75L;
• Age ≥ 18 years old;
• ECOG PS score ≤ 2;
• Estimated survival period ≥ 6 months;
• Women must undergo surgical sterilization, post-menopausal, or take contraceptive measures during the treatment period and within 3 months after the end;
• Sign the informed consent form.

You may not qualify if:

• Previously received other anti-tumor treatment, including almonertinib or other EGFR-TKI drugs;
• Contraindications for radiotherapy such as uncontrolled systemic lupus erythematosus, scleroderma or other connective tissue diseases;
• Other malignant tumors within 5 years (except for non-melanoma skin cancer and cervical cancer);
• Any medical or non-medical reasons prevent the patient from continuing to participate in the research;
• It is expected that the patient will not be able to comply with the research procedures, restrictions and requirements, and researchers determine that the patient is not suitable for participating in the trial;
• Currently receiving (or unable to stop using it before receiving the first dose of study treatment) drugs or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks ago);
• The patient is taking any drugs that prolong the QT interval, and the drug cannot be stopped before the treatment of almonertinib;
• Patients with lung V20 \> 28% even after two-month almonertinib treatment.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• Hangzhou Cancer Hospital: collaborator

Study Sites (1)

Hangzhou Cancer hospital

Hangzhou, Zhejiang, 310002, China

RECRUITING

Related Publications (1)

• Zhu L, Zou C, Zhang Z, Wang J, Yang L, Rao C, Yang Z, Liang J, Xia B, Shenglin MA. Thoracic radiotherapy and concurrent almonertinib for unresectable stage III EGFR-mutated non-small-cell lung cancer: a phase 2 study. BMC Cancer. 2021 May 7;21(1):511. doi: 10.1186/s12885-021-08266-w.

  PMID: 33962566 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Radiation Pneumonitis; Lung Neoplasms

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Shenglin Ma, M.D

CONTACT

086-0571-56006013; Mashenglin@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 19, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)