Study Using a Drug-device Combination Product to Determine Safety, Tolerability and Antitumor Activity for Patients With Advanced, Non-small Cell Lung Cancer
A Phase 1/2 Open-label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NHT102 (5-Azacytidine Dry Powder Formulation Delivered by a Novel Inhalation Delivery System) in Patients With Advanced Non-Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety, best dose, and cancer-fighting effects of NHT102, a powder breathed into the lungs through a study device. It is for adults with non-small cell lung cancer that has stayed or come back after treatment and is still limited to the lung or chest area. Trained staff give all doses at the study site.
There are 3 parts to this clinical trial. The goal of this clinical trial (NHT102-001) is to learn how safe NHT102 is, what dose works best, and whether it can help treat advanced non-small cell lung cancer (NSCLC) that has come back or remained after earlier treatment and is still confined to the lung / chest region by providing targeted inhaled treatment directly to the lungs. NHT102 is a dry powder that participants breathe in through a mouthpiece using an investigational inhalation device. Doses are given at the study site by trained staff, not at home. NHT102 is taken on days 1-5 and days 15-19 of a 28-day cycle. The main questions this clinical trial aims to answer are: Part 1 (Dose Escalation): To look at up to five different increasing dose levels of NHT102 to see if they are safe and well-tolerated and if the body absorbs the medicine from the lungs. To see if up to two dose levels studied are not only safe, but also make the cancer slow its growth or lessen its spread. And to see the highest dose that is tolerated by participants. Part 2 (Dose Optimization): To further study at up to two dose levels from Part 1 and randomly assign participants in equal numbers to one of them to learn more about NHT102's safety, how well the drug is absorbed from the lungs and how well each dose level works against the NSCLC after at least 4 months. Then identify which of the two doses is chosen for further study. Part 3 (Dose Expansion): Take the dose chosen in from Part 2 and study it in more patients to continue look at the drug safety, how much of it is absorbed into the body from the lungs and if it works to stop or reduce the spread of NSCLC. Participants will: * Take NHT102 at the study site daily on days 1-5 days and days 15-19 during a 28-day cycle for as long as it is helping them and they can tolerate it. Treatment stops if the cancer worsens, if side effects become too difficult to manage, or if the participant or their doctor decides to stop. * Tell doctors and staff about all medications they are taking, any issues with their study medication and all side effects they may be having whether they are taking the medication that day or not. * Return for a safety visit about 30 days after their last dose, then receive phone calls about 3 months and 6 months later to check on their health.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 and able to understand and agree to join the study.
- Have stage I–III non-small cell lung cancer confirmed by testing, with cancer that stayed or came back only in the chest area.
- Have finished treatment meant to cure the cancer and be unable to get more treatment aimed at a cure. If the cancer has certain gene changes, the right targeted treatment must have been given or offered.
- Have at least one lung tumor that can be measured.
- Be able to care for yourself and be up and about at least half of waking hours. Be expected to live at least 12 weeks.
- Have enough lung function, complete reliable breathing tests, and use the inhaler. Blood counts and kidney, liver, and heart function must meet study limits.
- Meet the required wait after earlier treatment. Most earlier side effects must be mild or gone, and certain blood-support treatments must not have been used within 14 days before the first dose.
- Follow birth control rules if able to have children, and agree not to smoke or use inhaled substances during treatment.
Who can't join
- Cancer has spread beyond the lungs, chest lymph nodes, or the area between the lungs.
- Have had cancer treatment too recently, need ongoing cancer treatment or drugs that change immune activity, or use steroid pills, injections, or inhalers unless an exception applies.
- Have smoked within the past 6 months or have severe disease of the airways.
- Are allergic to any study drug or device ingredient, or cannot safely have the study procedures.
- Had radiation within 6 months, major surgery within 4 weeks, or a live vaccine within 2 weeks before the first dose.
- Have another cancer, unless it is one of the allowed low-risk types.
- Have serious heart or blood vessel disease, an uncontrolled health condition, an infection needing medicine through a vein, or a bleeding disorder not caused by cancer.
- Are pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Age ≥18 years * Able to provide informed consent * Able to perform acceptable and reproducible spirometry per ATS criteria * Able to perform inhalation maneuver * Histologically or cytologically confirmed NSCLC (squamous, adenocarcinoma, or large cell undifferentiated) * Stage I-III NSCLC per AJCC 9th edition with recurrent or persistent thoracic confined disease * Prior therapy with curative intent completed * Actionable genomic alterations must have been treated or offered appropriate targeted therapy * Not eligible for additional curative therapy * At least one measurable lung lesion per RECIST v1.1 (measurable extra-pulmonary thoracic lesions do not qualify unless a measurable lung lesion is also present) * ECOG performance status ≤2 * Life expectancy ≥12 weeks * Adequate hematologic, renal, hepatic, and cardiovascular function * Washout from prior therapy ≥30 days or ≥5 half lives * Adequate pulmonary reserve: FEV1 ≥50% predicted, FEV1/FVC ≥45%, and DLCO ≥50% predicted * No growth factor support, transfusions, or albumin within 14 days prior to first dose * Resolution of adverse effects of prior therapy to Grade ≤1 (except fatigue, alopecia, and peripheral neuropathy) * Contraception requirements for WOCBP and fertile men * Agreement to refrain from smoking or inhaled substances during treatment Exclusion Criteria: * Systemic metastases beyond the lung, thoracic lymph nodes, or mediastinum region * Anticancer therapy within 30 days or 5 half-lives, or current immunomodulator requirement * Hypersensitivity to study drug or device components * Concurrent anticancer therapy or immunomodulators * Systemic or inhaled corticosteroids (exceptions apply) * Active smokers within past 6 months * Severe airway disease (criteria defined) * Radiation therapy within 6 months * Contraindication to study procedures * Other malignancies except specified low risk types * Major surgery within 4 weeks * Clinically significant cardiovascular disease * Uncontrolled medical conditions * Active infection requiring IV therapy * Live vaccine within 2 weeks of Cycle 1 Day 1 * Bleeding disorder unrelated to cancer * Pregnancy or breastfeeding
Study sites (1)
OH
- Gabrail Cancer Center Research · Canton, OH 44718Carrie Smith, RN · Study contactNashat Gabrail, MD · Principal investigatorMore trials in Canton