Adjuvant Chemotherapy for Non-Small Cell Lung Cancer

Recruiting at 70 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

420 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a test that examines 14 genes to predict if early-stage lung cancer will return or spread after surgery. It targets patients with Stage I or Stage IIA non-small cell lung cancer who are at high risk. The test helps doctors decide if additional treatment like chemotherapy is needed.

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.

What data supports the idea that Adjuvant Chemotherapy for Non-Small Cell Lung Cancer is an effective treatment?

The available research shows that adjuvant chemotherapy, which is a treatment given after surgery, can improve survival rates for patients with non-small cell lung cancer. For example, one study found that this treatment increased 5-year survival rates by 4% to 15%. Another analysis showed a 5.4% increase in survival rates when using a specific drug combination. These studies suggest that adjuvant chemotherapy can help patients live longer after their cancer has been surgically removed. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Adjuvant Chemotherapy for Non-Small Cell Lung Cancer?

Research shows that adjuvant chemotherapy, especially with cisplatin-based drugs, can improve the 5-year survival rates of patients with non-small cell lung cancer by 4% to 15% after surgery. This treatment is particularly beneficial for patients with completely resected tumors, providing a survival advantage of about 5% at 5 years. ^{1 2 3 4 5}

What safety data exists for adjuvant chemotherapy in non-small cell lung cancer?

Safety data for adjuvant chemotherapy in non-small cell lung cancer includes information on adverse effects, particularly in early-stage populations and long-term survivors, as well as treatment-related toxicity observed in the general population. Studies have evaluated the safety profile in older patients and the impact of delayed chemotherapy initiation on patient tolerance. ^{6 7 8 9 10}

Is adjuvant chemotherapy generally safe for humans?

Adjuvant chemotherapy for non-small cell lung cancer has been studied for its safety, with some reports of unresolved adverse effects, especially in early-stage patients or long-term survivors. The safety profile has been evaluated in older patients, showing that while it can be beneficial, there are risks of treatment-related toxicity. ^{6 7 8 9 10}

Is adjuvant chemotherapy a promising treatment for non-small cell lung cancer?

Yes, adjuvant chemotherapy is a promising treatment for non-small cell lung cancer. It has been shown to improve survival rates for patients who have had surgery to remove the cancer. Studies have found that it can increase the 5-year survival rates by 4% to 15%, making it a standard treatment option for these patients. ^{1 4 11 12 13}

How is adjuvant chemotherapy for non-small cell lung cancer different from other treatments?

Adjuvant chemotherapy for non-small cell lung cancer (NSCLC) is unique because it is given after surgery to help prevent cancer from coming back, and it typically involves a combination of drugs like cisplatin and vinorelbine. This approach has been shown to improve survival rates by 4% to 15% in patients with completely resected NSCLC, making it a standard treatment option. ^{1 4 11 12 13}

Research Team

David R Spigel, MD

Principal Investigator

Sarah Cannon, The Cancer Institute of HCA Healthcare

Eligibility Criteria

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.

I am 18 years old or older.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 (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]

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]

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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical study of post-operative adjuvant chemotherapy in non-small cell lung cancer]. [2010]

2. Greece 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. [2022]

4. China pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy after pulmonary resection for lung cancer. [2018]

6. Greece 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. [2023]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy for non-small cell lung cancer: practice patterns and outcomes in the general population of Ontario, Canada. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Association of Delayed Adjuvant Chemotherapy With Survival After Lung Cancer Surgery. [2023]

10. Japan 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. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Role of adjuvant chemotherapy in the treatment of non-small-cell lung cancer. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Adjuvant therapy of operable nonsmall cell lung cancer: an update. [2021]

13. England 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. [2020]