NSCLC Beyond Smoking: Why Non-Smokers Are an Emerging High-Risk Group

For decades, lung cancer has been synonymous with smoking; yet growing evidence challenges this assumption. Today, never-smokers account for up to 25% of non-small cell lung cancer (NSCLC) cases worldwide, establishing them as a distinct and increasingly recognized at-risk population[1].

While tobacco remains the dominant overall cause, NSCLC in never-smokers arises from a complex interplay of environmental exposures, genetic susceptibility, and biological risk factors that often go unrecognized. Because these individuals are not traditionally considered at risk, diagnosis frequently occurs at more advanced stages, when treatment options are more limited and outcomes poorer.

This epidemiological shift signals an urgent need to rethink how lung cancer risk is understood, identified, and addressed.

A Convergence of Overlooked Risk Factors

In never-smookers, NSCLC rarely results from a single cause. Instead, risk accumulates gradually through chronic exposures and underlying predispositions.

Second-hand smoke remains a significant contributor, increasing lung cancer risk by 20-30% due to prolonged inhalation of carcinogens present in tobacco emissions[2].

Radon gas represents another major but often invisible threat. This naturally occurring radioactive gas seeps into buildings from soil and rock, emitting alpha particles that damage lung tissue DNA. Radon exposure accounts for approximately 10% of lung cancer cases in never-smokers, making home testing and corrective measures (such as installing ventilation or radon reduction systems) essential preventive steps if elevated levels are detected[3].

Air pollution is also a critical driver. Fine particulate matter (PM2.5), generated by traffic, industrial activity, and biomass burning, penetrates deep into the lungs, triggering inflammation, oxidative stress, and genetic mutations. This risk is particularly pronounced in densely populated urban regions, where exposure is chronic and cumulative.

Occupational hazards further compound susceptibility. Long-term exposure to asbestos, silica, diesel exhaust, arsenic, and industrial chemicals (common in mining, manufacturing, and construction) has been strongly linked to increased NSCLC risk.

Genetics also play a defining role; never-smokers with NSCLC are significantly more likely to harbour specific molecular alterations, particularly mutations in the EGFR gene, which occur in up to 50% of Asian never-smokers. Family history, inherited genetic variants (e.g. KRAS), and hormonal influences, especially estrogen signaling in postmenopausal women, further shape individual risk profiles.

Additional contributors, including chronic lung disease such as chronic obstructive pulmonary disorder (COPD), pulmonary fibrosis, prior infections, and even prolonged exposure to cooking fumes indoors, add further lays of risk[4].

Taken together, these factors create a distinct disease pathway: one that develops largely outside the traditional smoking paradigm.

A Global Rise that is Reshaping Lung Cancer Epidemiology

The growing incidence of NSCLC in never-smokers is not anecdotal; it is measurable and accelerating.

Today, never-smokers represent between 15% and 25% of all lung cancer cases globally. Since 2000, diagnoses in this group have increased substantially, by between 30% and 50%, particularly in urban regions across Asia and North America[5].

The trend is especially striking among women. In East Asia, more than half of women diagnosed with NSCLC have never smoked[6]. Urbanization, environmental exposures, and demographic shifts all contribute to this rise.

Air pollution is now recognized as one of the most important drivers of this increase. Chronic exposure to PM2.5 and nitrogen dioxide contributes to genetic alterations associated with lung cancer, including EGFR mutations that define many never-smoker tumors[7].

Indoor pollution, particularly from biomass cooking fuels used in poorly ventilated environments, further elevates lifetime risk[8].

Meanwhile, radon exposure, occupational inhalants, and second-hand smoke continue to contribute to disease burden, even as smoking prevalence declines[9].

The result is a growing population developing lung cancer without ever smoking — a reality that challenges long-standing assumptions about who is at risk.

A Biologically Distinct Disease

NSCLC in never-smokers is not simply lung cancer without tobacco exposure. It is a biologically distinct disease.

Tumors in never-smokers are likelier to be adenocarcinomas arising in the lung periphery and driven by specific molecular alterations, including EGFR, ALK, ROS1, and HER2 mutations. These molecular differences have important clinical implications. They influence how the disease develops, how it progresses, and how it responds to treatment, often making targeted therapies more effective than conventional chemotherapy.

Genetic susceptibility also plays an important role, with germline variants in cancer-related genes such as EGFR, TP53, and HER2 associated with increased likelihood of NSCLC in never-smokers[10]. Consistent with this, individuals with a family history of lung cancer face elevated risk even in the absence of smoking. Hormonal signaling, particularly involving estrogen, may further influence tumor development, helping explain the higher incidence observed in women.

Chronic inflammation caused by environmental exposures further contributes to cancer development. Air pollutants such as PM2.5, nitrogen oxides, and volatile organic compounds can trigger persistent inflammatory and epigenetic changes in lung tissue[11]. In heavily polluted urban regions, such as megacities in East and South Asia, these exposures have been associated with a 20-40% increase in NSCLC risk among never-smokers. Indoor biomass fuels, occupational inhalants, and radon exposure similarly promote long-term tissue damage, fibrosis, and DNA alterations that create conditions favorable to tumor formation.

by pollution, infection, or lung disease further creates an environment conducive to cancer development.

Together, these findings reinforce the need to view NSCLC in never-smokers as a distinct clinical and public health challenge.

Why this Shift Demands a New Approach

Despite this growing risk, lung cancer awareness, screening, and diagnostic strategies remain largely focused on smokers. This gap has real consequences.

Never-smokers, and the clinicians treating them, are often less likely to suspect lung cancer, delaying diagnosis. Symptoms such as persistent cough, fatigue, or shortness of breath may be attributed to less serious conditions, allowing disease to progress unchecked.

Screening guidelines also remain heavily tied to smoking history. Low-dose CT screening, proven to detect lung cancer and reduce mortality, is currently recommended primarily for individuals with significant smoking exposure.

Yet emerging evidence suggests that targeted screening in high-risk never-smoker populations, such as those with high pollution exposure, genetic predisposition, or occupational risk could significantly improve early detection and survival.

This includes:

• Increasing awareness that lung cancer can occur in never-smokers

• Expanding risk assessment beyond smoking history alone

• Integrating environmental and genetic risk factors into screening decisions

• Improving access to molecular profiling to guide precision treatment

• Strengthening environmental protections to reduce preventable exposures

Rethinking Lung Cancer Risk

The rise in NSCLC among never-smokers represents a significant shift in how lung cancer risk is understood. It challenges outdated assumptions, exposes gaps in prevention and detection, and it highlights the need for a broader, more inclusive understanding of lung cancer risk.

Most importantly, it reinforces a critical reality: smoking is not a prerequisite for developing lung cancer. Recognizing this shift is essential to ensuring earlier diagnosis, more effective treatment, and better outcomes for a growing, and often overlooked, population.

Screening paradigms require expansion beyond smoker-centric low-dose CT (LDCT) criteria, like the outdated 30-pack-year threshold, to encompass non-smoker high-risk strata such as those in radon hotspots or polluted megacities. Pilot programs in Asia demonstrate that inclusive LDCT offered annually to genetically susceptible urban non-smokers yields 15-20% mortality reductions via early detection of indolent nodules amenable to sub lobar resection or targeted therapies. Policy integration of genomic profiling and exposure mapping ensures equitable access, transforming NSCLC from a fatal inevitability into a manageable chronic condition for this burgeoning cohort.

References:

1. Hendriks, L. E., Remon, J., Faivre-Finn, C., Garassino, M. C., Heymach, J. V., Kerr, K. M., Tan, D. S. W., Veronesi, G. & Reck, M. (2024). Non-small-cell lung cancer. Nature Reviews Disease Primers, 10 (1), 71. doi: https://doi.org/10.1038/s41572-024-00551-9

2. Yusuf, M. H. M., Zambri, S. N., Tajuddin, N. A. N. B. A., & Hairi, F. B. M. (2025). Health Impacts of Smoking. doi: https://doi.org/10.5772/intechopen.1010561

3. Ermayanti, S., & Fitrina, D. W. (2022). Effect of radon and lung cancer risk: a narrative literature review. Bioscientia Medicina: Journal of Biomedicine and Translational Research, 6 (15), 2691-2698. doi: https://doi.org/10.37275/bsm.v6i15.669

4. Ganie, F. A., ud Wani, N., & Gani, M. (2025). Exposure to indoor household air pollution and its impact. In Hazardous Chemicals (pp. 765-773). Academic Press. doi: https://doi.org/10.1016/B978-0-323-95235-4.00040-2

5. Chen, P. M., Huang, Y. H., & Li, C. Y. (2026). Lung Cancer in Never-Smokers: Risk Factors, Driver Mutations, and Therapeutic Advances. Diagnostics, 16 (2), 245. doi: https://doi.org/10.3390/diagnostics16020245

6. Gomez, S. L., DeRouen, M., Chen Jr, M. S., Wakelee, H., Velotta, J. B., Sakoda, L. C., … & Cheng, I. (2025). Elevated risk of lung cancer among Asian American women who have never smoked: an emerging cancer disparity. JNCI: Journal of the National Cancer Institute, 117 (6), 1104-1109.

7. Gavito-Covarrubias, D., Ramírez-Díaz, I., Guzmán-Linares, J., Limón, I. D., Manuel-Sánchez, D. M., Molina-Herrera, A., … & Rubio, K. (2024). Epigenetic mechanisms of particulate matter exposure: air pollution and hazards on human health. Frontiers in Genetics, 14, 1306600. doi: https://doi.org/10.3389/fgene.2023.1306600

8. Gopalakrishnan, N. K., Ansar, S. S., Pappuswamy, M., & Chaudhary, A. (2025). Comparative Analysis of Carcinogenic Compounds in Cooking Oil Emissions and Cigarette Smoke: Implications for Genetic Disorders and Cancer Susceptibility. doi: https://doi.org/10.5772/intechopen.1006096

9. Marie Quinn, A., G Newman, W., & S Hasleton, P. (2016). Risk factors for lung cancer in never smokers: A recent review including genetics. Current Respiratory Medicine Reviews, 12 (1), 74-117.

10. Smolle, E., & Pichler, M. (2019). Non-smoking-associated lung cancer: a distinct entity in terms of tumor biology, patient characteristics and impact of hereditary cancer predisposition. Cancers, 11 (2), 204. doi: https://doi.org/10.3390/cancers11020204

11. Campbell, L. (2025). Air Pollution and Epigenetic Modifications: Unveiling the Molecular Mechanisms in Cardiovascular Disease Progression. doi:

Jacek Antas

Chief Executive Officer


Jacek Antas is a shareholder of the Company, has spent more than 25 years in the financial services industry holding various positions in sales and consulting.

Mr. Antas obtained a master’s degree from the Warsaw School of Economics and has served as a board member of various
companies throughout his career.

This will close in 0 seconds

James B. Murphy

Chief Financial Officer


Mr. Murphy is a certified public accountant with over thirty years of experience in finance and operations management. He is currently a consultant with Danforth Advisors LLC (“Danforth”), a leading provider of outsourced strategic and operational specialists across functions in the life sciences industry. While at Danforth, Mr. Murphy has served over fifteen private and publicly held life sciences companies as CFO and CFO Advisor, helping them secure over USD 0.5 billion in financing and successfully execute pivotal asset transactions. Mr. Murphy functions as a consultant to Helix pursuant to a consulting agreement between the Company and Danforth.

This will close in 0 seconds

Thomas Mehrling

Medical Adviser


Thomas Mehrling (PhD in Pharmacology and MD) has over 20 years’ experience in multinational Pharma companies developing novel oncology compounds from preclinical research through to registration. Prior to entering the industry, he spent 13 years as an MD at the University Hospital in Frankfurt, working on preclinical and translational projects. He served as Director of European Oncology at Mundipharma International (2003–2013), building the company’s first European oncology business from the ground up out of Cambridge, UK, and completing the clinical development, registration and launch of two major products in Europe, DepoCyte® and Levact® (Ribomustin® and Treanda®). In 2013, he led the establishment of the Mundipharma Group’s start-up, Mundipharma EDO, developing anti-cancer therapeutics for solid tumours out of Basel, Switzerland.

This will close in 0 seconds

Kim Gaspar

Director Quality Assurance


Kim is the Director of Quality Assurance at Helix BioPharma Corp. An experienced quality assurance professional with expertise in Canadian, US, and EU regulations, she has been involved in all aspects of Phase I/II biopharmaceutical product development over the years, including regulatory submissions, QC laboratory compliance, tech transfer and third-party oversight of CMC activities, clinical QA, and bioanalytical data analysis. Kim joined Helix in 2000, transitioning into QA in 2003. She holds a B.Sc in Biochemistry and a Ph.D in Veterinary Physiological Sciences, both from the University of Saskatchewan.

This will close in 0 seconds

Brenda Lee

Director Clinical Operations


Brenda is the Clinical Operations Director at Helix Biopharma Corp. A clinical research operations professional with 25 years of experience managing clinical trials, ranging from early Phase I to late Phase IIIb/IV studies, she brings experience in clinical study protocol writing and development, trial start-up and vendor management, and a proven track record in planning and managing clinical trials to quality standards, timelines and budget. Brenda joined Helix Biopharma Corp. in 2018, working to advance the clinical program of L-DOS47. She holds B.Sc and M.Sc. degrees from the University of Toronto, specializing in Nutritional Sciences and Human Biology.

This will close in 0 seconds

Jerzy Leszczynski

Director


Jerzy Leszczynski is a shareholder of the Company, has spent more than 35 years developing businesses and has served in the capacity of board member of various real estate development companies. Mr. Leszczynski obtained his Master of Science in Chemistry from the Warsaw Institute of Technology.

This will close in 0 seconds

Janusz Grabski

Director, Chair of Audit Committee


Janusz (John) Grabski is a lawyer specialized in corporate and real estate law with over twenty years of experience.

This will close in 0 seconds

Malgorzata Laube

Director


Malgorzata Laube has over 19 years of experience in nuclear medicine. In her last role with Alberta Health Services, she was the Department Supervisor, Nuclear Medicine at Royal Alexandra Hospital. Ms. Laube obtained a MSc degree in Environmental Engineering from the Warsaw University of Technology and is based in Edmonton, Alberta, Canada.

This will close in 0 seconds

Jacek Antas

Chairman of the Board


Jacek Antas is a shareholder of the Company, has spent more than 25 years in the financial services industry holding various positions in sales and consulting.

Mr. Antas obtained a master’s degree from the Warsaw School of Economics and has served as a board member of various
companies throughout his career.

This will close in 0 seconds

Jonathan Davis

Advisor, ADC Discovery


Jonathan Davis received his Ph.D. from University of California, San Francisco, where he studied protein structure and function using NMR. After a post-doc at Harvard Medical School exploring RNA selection and structure in the labs of Jack Szostak and Gerhard Wagner, he went to work at EMD Serono, where his work involved improving antibody-based therapeutics, inventing a platform technology for generating heterodimeric Fcs as a basis for multifunctional molecules, and developing a novel scaffold based on an artificially-designed protein from David Baker’s lab. In 2008 he took a job at Bristol-Myers Squibb in Waltham/Cambridge MA, working on antibody discovery and platform development in a wide range of therapeutic areas, with a particular focus on multispecific therapeutics. He moved to Madison, WI in 2019 to take on the role of VP of Innovation and Strategy at Invenra, a biotech focused on bispecific antibodies, and where he is currently head of the Scientific Advisory Board. In early 2024 he left the corporate world to found Creative Antibodies, a consulting firm that helps guide companies to successful antibody discovery and development projects, from mAbs to multispecifics, ADCs, and other formats. Outside of science, Jonathan is a conservatory trained cellist, plays numerous other instruments, and founded the UCSF Orchestra (now Symphony Parnassus) in San Francisco, where he was Music Director for six years.

This will close in 0 seconds

Davide Guggi

Advisor, CMC


Davide graduated as a pharmacist and received his PhD in Pharmaceutical Technology and Biotechnology from the University of Vienna. He has over 20 years of experience in the pharmaceutical industry, principally in the field of oncology. At the beginning of his career, Davide led oncology business units and commercial departments at Mundipharma and Gilead across Austria and Eastern Europe. Since over 10 years he has been working as a CMC expert, covering operational and regulatory CMC functions on behalf of over 20 different small- and medium-sized biotech companies across the world. He has served as CMC Director and CSO/CTO for several years, developing both small molecules and biologics (mABs, Fab, ADCs and Radio-immuno-conjugates) from early discovery to NDA/BLA in the US, EU and Canada, with a focus on First-in-Human and Phase I/II studies in oncology indications.

This will close in 0 seconds

This will close in 0 seconds

Tumor Defense Breaker™, L-DOS47


L‑DOS47 is a first‑in‑class, clinical-stage antibody‑enzyme conjugate designed to deliver a game-changing assist to anti-cancer immunity and today’s leading cancer immunotherapies for the treatment of prevalent, hard-to-treat solid tumors. The compound precisely targets CEACAM6, a cell-surface protein overexpressed in non‑small cell lung cancer (NSCLC) and other aggressive tumors, where it delivers an enzymatic payload that raises the extracellular pH of the acidic tumor microenvironment (TME). By neutralizing tumor acidity, L-DOS47 restores immune cell infiltration and activity, helps turn immunologically “cold” tumors “hot”, and enhances the therapeutic reach of immune checkpoint inhibitors. With patented composition-of-matter coverage through 2036 and demonstrated synergy with PD-1 inhibitor, pembrolizumab, L-DOS47 is poised to significantly increase the efficacy of immune checkpoint blockade and unlock broader and more durable responses in NSCLC and other aggressive solid tumors.

This will close in 0 seconds

LEUMUNA™


LEUMUNA™ is an oral immune checkpoint modulator designed to activate the donor immune system to recognize and fight relapsing leukemia in patients who have undergone allogeneic stem cell transplantation (allo-SCT). Although a life-saving procedure, up to 30% of patients who undergo allo-SCT see their cancer return, facing a median survival of just four months. LEUMUNA aims to offer these patients a new lease on life, by activating an immune cascade and inciting graft-versus-leukemia (GvL) effect, potentially offering long-term remission. Backed by strong preclinical data and a promising safety record from trials with its precursor compound, ulodesine, LEUMUNA offers a patient‑friendly, oral approach to a difficult-to-treat condition, with patent protection through 2041 and an Orphan Drug Designation granted by the US FDA.

This will close in 0 seconds

GEMCEDA™


GEMCEDA is a first-in-class oral prodrug of gemcitabine that opens up the possibility for convenient at-home administration, metronomic dosing and seamless integration into combination regimens with immune checkpoint inhibitors. To date, gemcitabine is only administered intravenously because oral forms have shown poor bioavailability of about 10%. GEMCEDA was developed as a prodrug to enable new uses of gemcitabine by combining it with cedazuridine, an enzyme inhibitor that helps boost its bioavailability to 90%. This remarkable innovation allows for greater flexibility in dosing schedules, fewer clinic visits, and a better quality of life, while achieving bioavailability on par with intravenous gemcitabine. Supported by a well‑established safety profile, scalable manufacturing, and patent coverage to 2043, GEMCEDA reimagines how chemotherapy can fit into patients’ lives.

This will close in 0 seconds