Adjuvant Chemotherapy for Non-Small Cell Lung Cancer

Not currently recruiting at 77 trial locations

Overseen By Carolyn Clary, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Razor Genomics

Must not be taking: Systemic chemotherapy

Disqualifiers: Squamous cell, Small cell, Neuroendocrine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 cycles of chemotherapy

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best treatment for people with Stage I or IIA non-small cell lung cancer (NSCLC) after surgery. The researchers will compare two approaches: regular check-ups using scans or adding chemotherapy for those at higher risk of cancer returning. A special test will determine participants' risk of cancer recurrence. Individuals with completely removed Stage I or IIA non-squamous NSCLC who are at higher risk, according to the test, may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatment strategies.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for more information.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have been on systemic chemotherapy or anti-cancer agents in the last 5 years, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that chemotherapy given after surgery, known as adjuvant chemotherapy, can extend the lives of people with non-small cell lung cancer (NSCLC) after tumor removal. A large study found that cisplatin-based chemotherapy, a common form of this treatment, improved survival rates for these patients. However, this treatment can present challenges.

High rates of cancer recurrence exist, and some patients experience side effects that affect their health and quality of life. Anyone considering joining the trial should discuss the benefits and risks with their doctor, based on their personal health situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for adjuvant chemotherapy in non-small cell lung cancer because it uses a personalized approach with the 14-Gene Prognostic Assay. This test helps identify patients at intermediate or high risk, ensuring that only those who truly need chemotherapy receive it. Unlike standard care, which often uses a one-size-fits-all method, this approach tailors treatment to the individual's risk level, potentially improving outcomes and minimizing unnecessary side effects. By focusing on more precise patient selection, this trial could lead to more effective use of chemotherapy in lung cancer treatment.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that chemotherapy after surgery can extend the lives of people with early-stage non-small cell lung cancer (NSCLC). A large study found that cisplatin-based chemotherapy, a common treatment, improved survival rates after complete cancer removal. In this trial, participants identified as intermediate or high-risk by the 14-Gene Prognostic Assay may be randomized to receive Adjuvant Chemotherapy. Another study found that patients who received chemotherapy lived longer, with a 5-year survival rate 8.6% higher than those who did not. These findings suggest that chemotherapy can be a beneficial step after surgery, especially for those at higher risk. ^{1 2 4 6 7}

Who Is on the Research Team?

David R Spigel, MD

Principal Investigator

Sarah Cannon, The Cancer Institute of HCA Healthcare

Are You a Good Fit for This Trial?

This trial is for adults who've had surgery to remove Stage I or IIA non-squamous NSCLC and are at high risk of the cancer returning. They must be able to undergo chemotherapy, have a life expectancy of over 5 years excluding their lung cancer diagnosis, and be in good physical condition with fully healed surgical incisions.

Inclusion Criteria

Excluding my lung cancer, my health suggests I could live 5 more years.

I have provided a tissue sample for a specific genetic test.

My early-stage lung cancer was completely removed by surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant chemotherapy or undergo radiographic surveillance based on risk assessment

4 cycles of chemotherapy

Follow-up

Participants are monitored for disease-free survival and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Adjuvant Chemotherapy

Trial Overview The study is testing if post-operative adjuvant chemotherapy can improve survival compared to just watching patients with radiographic surveillance after surgery. It uses a new tool called the 14-Gene Prognostic Assay to identify those at higher risk of death within five years from lung cancer.

How Is the Trial Designed?

Group I: Observation Active Control 2 Interventions

Post-operative observation of Stage I or Stage IIA non squamous non-small cell lunger cancer with Radiographic Surveillance is a current standard of care. Patients identified as low risk will be observation. Those patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Adjuvant Chemotherapy Arm.

Group II: Adjuvant Chemotherapy Active Control 2 Interventions

Adjuvant Chemotherapy is a current standard of care for intermediate or high-risk Stage I or Stage IIA non-squamous non-small cell lung cancer. Patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Observation Arm.

Who Is Running the Clinical Trial?

Razor Genomics

Lead Sponsor

Trials

1

Recruited

420+

Encore Clinical

Collaborator

Trials

1

Recruited

420+

Published Research Related to This Trial

A study of 12,473 patients with completely resected non-small-cell lung cancer found that starting adjuvant chemotherapy around 50 days after surgery is associated with the lowest mortality risk.

Patients who began chemotherapy 7 to 18 weeks post-surgery still experienced significant survival benefits, indicating that those who need more recovery time can still effectively receive treatment up to 4 months after their operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Delayed Adjuvant Chemotherapy With Survival After Lung Cancer Surgery. Salazar, MC., Rosen, JE., Wang, Z., et al.[2023]

Adjuvant chemotherapy, particularly with a cisplatin-based doublet like cisplatin plus vinorelbine, has been shown to improve 5-year survival rates for patients with completely resected non-small cell lung cancer (NSCLC) by 4% to 15% in randomized trials.

Future advancements in adjuvant therapy outcomes are anticipated through personalized chemotherapy approaches and the incorporation of targeted therapies or immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. Pirker, R.[2022]

In a study of 64 patients with stage IB-IIIA non-small cell lung cancer (NSCLC), those who received adjuvant chemotherapy showed significantly better survival rates at 3 and 4 years compared to those who did not receive chemotherapy, with survival rates of 71.4% and 58.4% versus 63.5% and 43.1%, respectively.

The median survival time was also improved in the chemotherapy group, with 52 months compared to 47 months in the observation group, indicating that cisplatin- or carboplatin-based adjuvant chemotherapy can effectively enhance survival after complete tumor resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study of post-operative adjuvant chemotherapy in non-small cell lung cancer]. Song, W., Wang, W., Shang, L., et al.[2010]

Patients with non-small-cell lung cancer (NSCLC) who have preoperative sarcopenia and a history of smoking are at a higher risk for developing postoperative pulmonary complications and infections after surgery.

Advanced tumor stage, high neutrophil-to-lymphocyte ratio, and the use of traditional open thoracotomy are significant risk factors that negatively impact overall and disease-free survival in NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Assessment of the Clinical Risk Factors of Postoperative Adverse Events and Survival in Patients With Non-small-cell Lung Cancer. Chang, BS., Peng, TC., Lue, KH., et al.[2023]

Adjuvant chemotherapy can provide a modest increase in survival for patients with non-small-cell lung cancer (NSCLC), but its overall effectiveness is inconsistent and not universally beneficial, as many patients are not candidates for surgery.

The International Adjuvant Lung Cancer Trial (IALT) is the largest study showing this modest survival benefit, and platinum-based chemotherapy regimens are the most researched options, though further studies are needed to optimize treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of adjuvant chemotherapy in the treatment of non-small-cell lung cancer. Wilhelm, L., Kolesar, JM.[2019]

In a study of 132 patients with completely resected non-small-cell lung cancer, the combination of cisplatin and pemetrexed (CPx) demonstrated a significantly higher feasibility rate (95.5%) compared to cisplatin and vinorelbine (CVb) at 75.4%, indicating better tolerability and safety.

CPx also resulted in much lower rates of severe hematological toxic effects (10% for CPx vs. 74% for CVb), while achieving a higher mean dose delivery (90% of planned for CPx vs. 66% for cisplatin and 64% for vinorelbine in CVb), suggesting it is a more effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study. Kreuter, M., Vansteenkiste, J., Fischer, JR., et al.[2020]

In a study of 1,032 patients with early-stage non-small cell lung cancer who received adjuvant chemotherapy (ACT), the most common regimens were cisplatin-based, with a significant portion (64%) experiencing dose reductions or omissions without negatively impacting survival rates.

The overall survival outcomes for patients receiving ACT in this general population study were comparable to those reported in clinical trials, indicating that real-world effectiveness and safety profiles align with controlled study results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy for non-small cell lung cancer: practice patterns and outcomes in the general population of Ontario, Canada. Booth, CM., Shepherd, FA., Peng, Y., et al.[2018]

Adjuvant chemotherapy with a cisplatin-based regimen is recommended for patients with stage II and III non-small cell lung cancer (NSCLC) after complete tumor removal, and may also be considered for stage IB patients.

This treatment provides an approximate 5% absolute survival advantage at 5 years, but there remains a significant risk of relapse, highlighting the need for new therapies and personalized treatment approaches based on biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy after pulmonary resection for lung cancer. Mascaux, C., Shepherd, FA.[2018]

Cisplatin-based chemotherapy remains the standard postoperative treatment for stage II-III nonsmall cell lung cancer (NSCLC), but its benefits are limited, highlighting the need for improved therapies.

Postoperative treatment with osimertinib has shown remarkable efficacy, significantly prolonging disease-free survival in patients with resected stage II/IIIA NSCLC with EGFR mutations, as demonstrated by a hazard ratio of 0.17 in the ADAURA study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant therapy of operable nonsmall cell lung cancer: an update. Mitsudomi, T., Soh, J.[2021]

Adjuvant chemotherapy (ACT) after surgical resection for stage II-III non-small cell lung cancer (NSCLC) in patients aged 75 years or older shows a significant survival benefit, with improved relapse-free survival (36 months vs. 18.5 months) and overall survival (not reached vs. 33.5 months).

While 21% of the 140 evaluated patients received ACT, common adverse effects included anemia and neutropenia, but no toxic deaths occurred, indicating that ACT has a manageable safety profile in this older population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major clinical benefit from adjuvant chemotherapy for stage II-III non-small cell lung cancer patients aged 75 years or older: a propensity score-matched analysis. Blasi, M., Eichhorn, ME., Christopoulos, P., et al.[2022]

Postoperative cisplatin-based chemotherapy significantly improves overall survival in patients with non-small-cell lung cancer (NSCLC), with a 5-year absolute survival benefit of 5.4% based on a pooled analysis of 4,584 patients from five major trials.

The effectiveness of chemotherapy varies by cancer stage, showing the most benefit in stage II and III patients, while those with stage IA showed no significant benefit, indicating that treatment decisions may need to be tailored based on the stage of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. Pignon, JP., Tribodet, H., Scagliotti, GV., et al.[2022]

A mathematical model was used to analyze the balance between the benefits of adjuvant chemotherapy (Adj.C) in eliminating micro-metastasis and the potential life-threatening adverse effects in patients with completely resected non-small cell lung cancer (NSCLC).

The study found that the survival benefit of Adj.C varies by cancer stage, with theoretical and reported outcomes closely aligning, suggesting that while Adj.C can improve survival, it also carries significant risks that need to be considered, especially in early-stage patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substantial risk affects the stage-dependent outcomes of cisplatin-based adjuvant chemotherapy for completely resected non-small cell lung cancer. Yoshino, I.[2021]

In a study of 67 patients with non-small cell lung cancer (NSCLC), a bi-weekly chemotherapy regimen of carboplatin and paclitaxel showed acceptable toxicity, with only 13.4% experiencing severe neutropenia and no treatment-related deaths.

The treatment resulted in high disease-free survival and overall survival rates at 2 years, estimated at 89.0% and 88.8%, respectively, suggesting that this chemotherapy regimen is both effective and feasible for patients after complete tumor resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of adjuvant chemotherapy with bi-weekly carboplatin plus paclitaxel in patients with completely resected non-small cell lung cancer. Sugaya, M., Uramoto, H., Uchiyama, A., et al.[2022]

Citations

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Real-world outcomes and toxicity of adjuvant ... High rates of disease recurrence and treatment-associated morbidity were observed in patients receiving adjuvant chemotherapy for NSCLC. Novel ...

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Clinical Outcomes of Perioperative Immunotherapy in ... This cohort study evaluates the adoption and survival outcomes of US Food and Drug Administration–approved chemoimmunotherapies in the ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa031644

Cisplatin-Based Adjuvant Chemotherapy in Patients with ... This large trial showed that cisplatin-based chemotherapy improves survival among patients who have undergone complete resection of non–small-cell lung cancer.

4. jto.org jto.org/article/S1556-0864(15)32563-6/fulltext

Adjuvant Chemotherapy for Non-small Cell Lung Cancer Adjuvant chemotherapy (ACT) is known to improve survival in patients with early-stage non-small cell lung cancer. Herein, we describe chemotherapy regimens ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3228021/

Adjuvant Therapy in Non-Small Cell Lung Cancer Similarly, in the ANITA study, the OS rate at 5 years was 8.6% higher in the chemotherapy arm, and this survival advantage was maintained at 7 years (8.4%) [7].

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1043067905000432

Adjuvant Chemotherapy for Non-Small Cell Lung Cancer Until recently, the use of adjuvant therapy after resection for early stage disease has not been proven to improve survival.

7. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-481060

Surgical and Perioperative Advances for Patients With ... Among 2,385 patients, preoperative chemotherapy significantly improved survival with an HR of 0.87 (95% CI, 0.78 to 0.96; P = .007). This ...