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

A Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer

This trial will test whether adding nanocrystalline megestrol acetate to standard concurrent chemoradiotherapy helps improve appetite and body weight in adults with stage III non-small cell lung cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07150663 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically or cytologically confirmed unresectable stage III non-small cell lung cancer who are planned for radical concurrent chemoradiotherapy, have ECOG performance status 0–2, BMI ≤25, expected survival ≥6 months, and at least one measurable tumor are the intended participants.

Not a fit: Patients with conditions that impair gastrointestinal absorption, those receiving tube feeding or parenteral nutrition, or whose anorexia is due to primary neurological or psychiatric causes are unlikely to benefit from the oral megestrol intervention.

Why it matters

Potential benefit: If successful, adding nanocrystalline megestrol acetate could help patients maintain appetite and body weight during chemoradiotherapy, potentially improving treatment tolerance and quality of life.

How similar studies have performed: Megestrol acetate has previously shown benefit for cancer-related anorexia and weight gain in other settings, but using a nanocrystalline oral suspension specifically during concurrent chemoradiotherapy is a more novel application with limited phase 3 evidence to date.

Eligibility criteria

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 this trial is running

Wuhan, Hubei

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

Study contacts

• Study coordinator: qian Chu

Conditions Non-small Cell Lung Cancer