Early identification of lung cancer markedly improved patients survival by detecting malignancies at an earlier, more manageable stage. Advanced in diagnostic imaging and screening enhanced the accuracy of early detection, helping to enable timely intervention. Participation in clinical trials provides clinicians with opportunities to connect eligible patients to therapies that may not yet be widely available. Ongoing awareness of emerging clinical research ensures clinicians remain aligned with the latest evidence-based practices in early lung cancer care.
The following are U.S.-based clinical trials focused on early-stage lung cancer that are currently recruiting or anticipated to begin recruiting soon.
Featured Early Lung Cancer Clinical Trials Comparison Table
| Study Title | Phase | Recruiting? | Estimated Enrollment | Study Start | Estimated Primary Completion |
|---|---|---|---|---|---|
| Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment | 3 | Not Yet | 400 | December 2025 (estimated) | February 2032 |
| A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection (REZILIENT4) | 3 | Recruiting | 360 | November 2025 | October 2029 |
| Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) | 1,2 | Not Yet | 60 | November 2025 | December 2031 |
| Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC | 1,2 | Recruiting | 21 | March 2024 | April 2026 |
| Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (NeoCOAST-2) | 2 | Recruiting | 630 | April 2022 | May 2030 |
Early Lung Cancer Clinical Trials Rundown
Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
- Sponsor: Boehringer Ingelheim
- Goal: This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment.
- Interventions: Zongertinib, pemrolizumab, atezolizumab, durvalumab, nivolumab
- Primary Outcome Measure: Disease-free survival by investigator's assessment.
- Timeframe: Up to eight years and five months.
- Study Details
- Source
A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection (REZILIENT4)
- Sponsor: Taiho Oncology
- Goal: The purpose of this study is to compare the efficacy of zipalertinib combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in participants with early stage (stage IB-IIIA) resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).
- Interventions: Cisplatin, carboplatin, pemetrexed, TAS6417, Zipalertinib-matching placebo
- Primary Outcome Measure: Disease-free Survival as assessed by the investigator.
- Timeframe: Up to five years.
- Study Details
- Source
Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)
- Sponsor: National Cancer Institute
- Goal: To find the safest and most effective dose of inhaled azacytidine in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.
- Interventions: Azacytidine, carboplatin, paclitaxel, durvalumab, cisplatin, gemcitabine, pemetrexed
- Primary Outcome Measures: Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of neoadjuvant aerosolized AZA; Phase II: To determine the frequency of pathologic complete responses (pCR) in participants receiving aerosolized AZA, durvalumab, and SOC platinum-based chemotherapy as induction therapy for early-stage NSCLC.
- Timeframe: Starts at initiation of study drug, through end of DLT period; Baseline (pre treatment biopsy) and at the time of SOC surgery post cycle three.
- Study Details
- Source
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
- Sponsor: Icahn School of Medicine at Mount Sinai
- Goal: This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC).
- Interventions: Dupiluma, cemiplimab
- Primary Outcome Measures: Frequency of dose limiting toxicities; Percentage of dose limiting toxicities; Major pathological response.
- Timeframe: Up to 30 days post-treatment; Up to 30 days post-treatment; Day of surgery, scheduled within seven days of day 15.
- Study Details
- Source
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (NeoCOAST-2)
- Sponsor: AstraZeneca
- Goal: The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.
- Interventions: Durvalumab, oleclumab, monalizumab, dato-DXd, AZD0171, carboplatin, cisplatin, pemetrexed/cisplatin, pemetrexed/carboplatin, carboplatin/paclitaxel, volrustomig, and rilvegostomig.
- Primary Outcome Measures: Number of patients with pathological complete response; Number of participants with adverse events and serious adverse events.
- Timeframe: From randomization to approximately 15 weeks after the first dose of study interventions; Until day 90 after the last dose of study interventions (up to approximately three years).
- Study Details
- Source
Related Guidelines:
Diagnosis, Treatment and Follow-Up of Early and Locally Advanced Non-Small Cell Lung Cancer
- European Society for Medical Oncology (ESMO)
- August 2025
Staging and Multidisciplinary Management of Patients with Early-Stage Non-Small Cell Lung Cancer
- American Association for Thoracic Surgery (AATS)
- September 2023
- American Society of Clinical Oncology (ASCO)/Cancer Care Ontario (CCO)
- February 2022
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