Nanocrystalline megestrol acetate added to chemoradiotherapy for locally advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, prospective, randomized, parallel-controlled trial comparing oral nanocrystalline megestrol acetate plus standard concurrent chemoradiotherapy versus placebo plus standard therapy in patients with unresectable stage III non-small cell lung cancer. Participants must have ECOG 0-2, BMI ≤25, an expected survival of at least 6 months, and at least one measurable lesion by RECIST v1.1. The study drug is given as an oral suspension during the course of radical concurrent chemoradiotherapy, with efficacy endpoints focused on appetite and body weight and safety monitored throughout treatment. The trial is sponsored by Changchun GeneScience and conducted at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily provide written informed consent (ICF).
2. Age ≥ 18 years at enrollment.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
4. Expected survival ≥ 6 months.
5. Histologically or cytologically confirmed, unresectable or inoperable locally advanced (stage III) non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma) according to the 8th edition of the TNM classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
6. Planned to receive radical concurrent chemoradiotherapy.
7. Body mass index (BMI) ≤ 25.
8. At least one measurable tumor lesion according to RECIST v1.1.

Exclusion Criteria:

1. Presence of any condition affecting gastrointestinal absorption, such as difficulty swallowing, malabsorption, or uncontrollable vomiting; currently receiving tube feeding or parenteral nutrition; suffering from anorexia due to neurological or psychiatric disorders, or difficulty eating due to pain.
2. Currently taking or planning to take other medications that increase appetite or body weight, such as corticosteroids (excluding short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
3. Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes.
4. Postmenopausal women with a history of abnormal vaginal bleeding within one year; premenopausal women with a history of abnormal endometrial thickening (\>15 mm) within one year.
5. Current radiological or clinical evidence of gastrointestinal obstruction.

Where it's running

• Tongji Hospital, TongjiMedical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: qian Chu
• Email: qianchu@tjh.tjmu.edu.cn
• Phone: 13212760751

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.