Actively Recruiting

Phase 3
Age: 18Years - 85Years
All Genders
NCT07150663

Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-09-08

134

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

Sponsors

C

Changchun GeneScience Pharmaceutical Co., Ltd.

Lead Sponsor

T

Tongji Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the efficacy and safety of Nanocrystalline Megestrol Acetate combined with standard therapy, compared with placebo combined with standard therapy, in improving appetite and body weight during concurrent chemoradiotherapy for patients with locally advanced non-small cell lung cancer.

CONDITIONS

Official Title

Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent
  • Age 18 years or older at enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
  • Expected survival of at least 6 months
  • Histologically or cytologically confirmed unresectable or inoperable locally advanced (stage III) non-small cell lung cancer
  • Planned to receive radical concurrent chemoradiotherapy
  • Body mass index (BMI) 25 or less
  • At least one measurable tumor lesion according to RECIST v1.1
Not Eligible

You will not qualify if you...

  • Conditions affecting gastrointestinal absorption such as difficulty swallowing, malabsorption, or uncontrollable vomiting
  • Currently receiving tube feeding or parenteral nutrition
  • Anorexia due to neurological or psychiatric disorders or difficulty eating due to pain
  • Taking or planning to take other medications that increase appetite or body weight, including corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants
  • Having Cushing's syndrome, adrenal or pituitary insufficiency
  • Poorly controlled diabetes
  • Postmenopausal women with abnormal vaginal bleeding within one year
  • Premenopausal women with abnormal endometrial thickening (>15 mm) within one year
  • Current radiological or clinical evidence of gastrointestinal obstruction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tongji Hospital, TongjiMedical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

Q

qian Chu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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