Clinical Trial Landscape: Non-small Cell Lung Cancer (NSCLC)

Non-small cell lung cancer (NSCLC) continues to be a multifaceted challenge. Even with many new therapies being studied, the complicated nature of NSCLC requires detailed clinical research to find effective treatments. In this article, we look at the current NSCLC landscape, giving research professionals a data-based view of the NSCLC trial landscape, showing a wide pipeline across different stages and mechanisms, using real-world data from Citeline. We will end by pointing out Precision for Medicine’s past and present expertise in NSCLC. 

Exploring the landscape of NSCLC clinical trials

NSCLC, or non-small cell lung cancer, is the most common type of lung cancer, making up about 80-85% of all cases.¹ NSCLC generally grows and spreads more slowly than small-cell lung cancer (SCLC). There are more than 2 million new cases of lung cancer diagnosed each year, with the majority being NSCLC.²

• In the United States, there were an estimated 235,760 new cases of lung cancer in 2021, with approximately 189,100 of these being NSCLC.¹
• The incidence rate in the European Union varies by country, but overall, Europe sees about 313,000 new cases of lung cancer annually, with roughly 250,400 cases being NSCLC.³

Unfortunately, many NSCLC cases are diagnosed at a later stage. Around 57% of lung cancer cases in the US (combining both NSCLC and SCLC) are discovered at an advanced stage, where the cancer has spread.⁴

NSCLC trials by phase

Each phase of a NSCLC clinical trial is crucial for determining drug safety, dosing, and efficacy. The data indicate a significant number of trials in Phase II, with 1,352 out of 3,731 NSCLC trials,⁵ suggesting a robust pipeline of treatments at the proof-of-concept stage of development.

At Precision, our primary emphasis is on early phase trials, representing over 90% of our NSCLC studies. Focusing on phase I, I/II, and II trials means we are positioned to help accelerate early and proof-of-concept drug development. Such specialization underscores our early engagements with biotech and pharmaceutical entities, necessitating unique expertise.

Early phase trials often employ adaptive designs, adjusting future actions based on preliminary findings. A flexible approach that accommodates rapid changes in protocol design, patient populations, and scenario planning for expanding sites and countries is essential to successful NSCLC trial execution. This approach is technically more nuanced than traditional methodologies and requires an agile clinical operations team and close partnership between CRO and sponsor. 

Planned and Ongoing NSCLC Trials by Phase 

Precision’s experience in NSCLC research

In NSCLC research selecting an adept clinical trial partner is paramount. Precision for Medicine stands out as a leader with a comprehensive and influential track record that stretches over a decade.  

NSCLC clinical trial experience

Precision for Medicine has conducted 67 NSCLC trials, 40 of which were started in the last 5 years.

Precision for Medicine NSCLC Trials by Start Date 

Precision’s NSCLC Trials are Worldwide

Precision for Medicine has experience in all the countries where NSCLC research is booming, including China, the US, Spain, Japan, and France. However, our expertise is not limited to a single region. When it comes to NSCLC research, we have a strong presence in 45 countries, reflecting our global reach and the requirement for a broad geographic clinical trial footprint in the competitive NSCLC landscape. 

Precision for Medicine NSCLC Trial Experience by Country 

Deep early phase expertise in oncology

Precision for Medicine has supported 67 NSCLC clinical trials. We have built a wealth of knowledge and a firm understanding of best practices around NSCLC research. Most of our experience is within Phase I, I/II, and II trials. We have experience determining the safety and optimal dosage and examining the efficacy of new treatments. That said, we have worked on some large global registrational Phase III NSCLC trials. 

Precision for Medicine NSCLC Clinical Trials by Phase

Precision’s Experience by Line of Therapy

While trial phase is important when looking at expertise, there are other elements, especially in an indication as competitive as NSCLC. With that in mind, our experience in NSCLC clinical trials covers neoadjuvant patients through more advanced patients that have received multiple lines of therapy.

Precision NSCLC Trials by Therapeutic Class

At Precision for Medicine, we have been fortunate to partner with sponsors across a wide range of therapeutic modalities. Monoclonal antibody and small molecule tyrosine kinase inhibitor (TKI) research has been a focus within our NSCLC experience, but we have also participated in clinical trials that centered on a variety of other therapeutic modalities, including antibody-drug conjugates (ADCs), T cell engaging bispecifics, intratumorally injected innate immune agonists, and neoantigen vaccines. 

Modalities and drug targets studied with Precision

Precision for Medicine has studied a wide array of modalities and drug targets in NSCLC clinical trials. Our expertise is particularly notable with checkpoint inhibitors which are included in 42% of our NSCLC clinical trials and are frequently tested in combination with other investigational agents.  

Our checkpoint inhibitor experience in NSCLC not only encompasses first-generation checkpoint inhibitors and targets (CTLA-4, PD-1, and PD-L1), but also next generation targets such as TIGIT, VISTA, KIR3DL3, LILRB2, and CD47. Precision’s experience with other immuno-oncology targets in NSCLC include T cell agonists, STING agonists, A2A receptor antagonists, and T cell therapies targeting neoantigens, hTERT, and mucin 1. 

Precision for Medicine NSCLC Therapeutic Modalities

In addition to extensive immuno-oncology experience, we have conducted research involving numerous other targets, each offering unique therapeutic potential against NSCLC. These targets include ALK (Anaplastic Lymphoma Kinase), BRAF (B-Raf Proto-Oncogene) MAP Kinase, ROS1 (c-ros oncogene 1), and VEGF (Vascular Endothelial Growth Factor). These are just a sampling of the many targets we have studied in our ongoing efforts to advance the field of NSCLC research.

Proceed with Precision for Your Next NSCLC Clinical Trial

Precision for Medicine is dedicated to innovations that change lives, and our work in Non-Small Cell Lung Cancer is a critical part of those efforts. To learn learn how we are pushing the boundaries of what’s possible in NSCLC research, explore the full breadth of our oncology CRO services.

Together, we can make strides towards conquering NSCLC, one trial at a time.

References:

1. American Cancer Society. Key Statistics for Lung Cancer. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed January 25, 2024.
2. World Cancer Research Fund International. Lung cancer statistics. https://www.wcrf.org/cancer-trends/lung-cancer-statistics/. Accessed January 25, 2024.
3. Organisation for Economic Co-operation and Development. Incidence, survival and mortality for lung cancer. https://www.oecd-ilibrary.org/sites/547f405e-en/index.html?itemId=/content/component/547f405e-en. Accessed January 25, 2024.
4. Thandra KC, Barsouk A, Saginala K, Aluru JS, Barsouk A. Epidemiology of lung cancer. Contemp Oncol (Pozn). 2021;25(1):45-52. doi:10.5114/wo.2021.103829
5. Trialtrove® | Citeline, 2024.
6. Data on file, Precision for Medicine.