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Ethanol

Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks

Maltose capsule, 300 mg/day, for eight weeks

ethanol-soluble fraction of water extract

Annona muricata extract

Placebo

Lili Indrawati, MSc

Annona muricata L., include the leaves, is found to contain biologically active Annonaceous acetogenins and plant polyphenols that are important components of human diet and a number of them are considered to have chemopreventive and therapeutic properties against cancer.

To confirm previous findings in in vitro, animal study and traditionally use, a human, ex vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of A. muricata leaves extract for eight weeks.

Colorectal cancer patients were randomly assigned to receive either A. muricata leaves extract or placebo. Dietary intakes and anthropometry were assessed with food record every two weeks. Blood parameters, nutritional status, quality of life, fecal butyrate level, and systemic inflammation of patient were assessed at the beginning and the end of study.

Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells

Effect of Annona Muricata Leaves on Nutritional Status, Quality of Life, Fecal Butyrate, Inflammation, and Colorectal Cancer Cells

Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay

Indonesia University

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participants with NSCLC with MET exon 14 skipping mutations, irrespective of MET gene copy number (GCN) will take 400 mg tablet orally twice per day

Participants with NSCLC with high level MET amplification will take 400 mg tablet orally twice per day

150 mg and 200 mg tablets for oral administration

capmatinib

The purpose of this study is to determine if neoadjuvant capmatinib can improve outcomes in participants with stages I-IIIA non-small cell lung cancer with MET exon 14 mutations and/or high MET amplification beyond those achieved with surgery, chemotherapy, and radiation.

This trial is a phase II, two cohort study of neoadjuvant capmatinib treatment (pre-surgery) which will be given for 8 weeks prior to a surgical resection and then followed by a three year adjuvant capmatinib treatment (post surgery). Following treatment, there will be a two year survival follow-up. The two molecularly defined cohorts will be enrolled in parallel. Approximately 38 evaluable participants will be enrolled in the study.

During treatment participants will visit their treating physician to assess overall health status which will include lab-work and other safety assessments. Survival follow-up will be every 6 months which can be conducted via a telephone visit for up to approximately 2 years after end of treatment.

Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC

Phase II Trial of Neoadjuvant and Adjuvant Capmatinib in Participants With Stages IB-IIIA, N2 and Selected IIIB (T3N2 or T4N2) NSCLC With MET Exon 14 Skipping Mutation or High MET Amplification (Geometry-N)

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

MPR rate in each cohort defined as the percentage of participants with ≤ 10% residual viable cancer cells

Complete pathologic response (pCR) rate is defined as the percentage of participants with no residual viable cancer cells.

Overall response rate (ORR) is defined as the percentage participants with best overall response (BOR) of complete response (CR) or partial response ( PR) according to RECIST v1.1

The occurrence of adverse events will be reported from first day of treatment through end of treatment plus 30 days.

Serious adverse events which are treatment related will be reported through the end of study participation. Adverse events also may be detected or through physical examination findings, laboratory test findings, or other assessments.

Defined as the time from end of surgery (start of adjuvant therapy) until the recurrence of cancer or death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells	NCT02439580	Colorectal Canc...	Annona muricata... Placebo	18 Years -	Indonesia University
Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC	NCT04926831	Non-small Cell ...	capmatinib	18 Years - 90 Years	Novartis

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